Chain Drug Review - FDA First-time generics approvals
FDA First-Time Generics Approvals–2004
GENERIC DRUG NAME MANUFACTURER BRAND NAME
JANUARY
Ketoconazole shampoo 2% Clay-Park Labs Inc. Nizoral shampoo
Hydrocortisone butyrate Taro Pharmaceutical Locoid solution
topical solution 0.1% Industries Ltd.
Metoprolol tartrate Caraco Pharmaceutical Lopressor tablets
tablets, USP 25 mg Laboratories Ltd.
Ibuprofen chewable L. Perrigo Co. Children’s Motrin
tablets 50 mg (orange 50 mg and Junior
and grape flavor) and Strength Motrin
100 mg (orange and
grape flavor)
FEBRUARY
Polyethylene glycol Schwarz Pharma Inc. Nulytely for oral
3350, kcl, NaHco3 and solution
Nacl for oral solution
420 g, 1.48 g,
5.72 g and 11.2 g,
respectively,
per bottle
Oxycodone HCl tablets, Amide Pharmaceutical Roxicodone
USP 15 mg and 30 mg Inc. tablets
Benazepril HCl tablets Ranbaxy Laboratories Lotensin tablets
5 mg, 10 mg, 20 mg and Lt.
40 mg
Benazepril HCl and Andrx Pharmaceuticals Lotensin HCT
hydro-chlorothiazide LLC tablets
tablets 5mg/6.25mg,
10 mg/12.5 mg, 20 mg/
12.5 mg and 20 mg/25 mg
Mercaptopurine tablets, Prometheus Purinethol tablets
USP 50 mg Laboratories, Inc.
Cefixime tablets, Lupin Ltd. Suprax tablets
USP 400 mg
Glyburide and metformin Ivax Pharmaceuticals Glucovance
HCl tablets 1.25 mg/250 Inc. tablets
mg, 2.5 mg/500 mg and 5
mg/500 mg
Cefixime for oral Lupin Ltd. Suprex for oral
suspension, USP suspension
100 mg/5 ml
Desogestrel and ethinyl Barr Laboratories Inc. Cyclessa tablets
estradiol tablets 0.10
mg/0.025 mg, 0.125 mg/
0.025 mg, 0.15 mg/0.025
mg; 28-day triphasic
regimen
Methamphetamine HCl Able Laboratories Desoxyn tablets
tablets, USP 5 mg
MARCH
Amoxicillin and Teva Pharmaceuticals Augmentin ES-
clavulanate potassium USA 600 for oral
for oral suspension, suspension
USP 600 mg/42.9 mg
(base)/5 ml
Deferoxamine mesylate Abbott Laboratories Desferal for
for injection, USP 500 injection
mg/vial and 2 g/vial
Naproxen sodium and L. Perrigo Co. Aleve Cold and
pseudoephedrine HCl Sinus extended-
extended-releasetable release tablets
200 mg (base)/120 mg
Hydrocodone bitartrate Interpharm Inc. Vicoprofen
and ibuprofen tablets 5 tablets
mg/200 mg
Bupropion HCl extended- Eon Labs Inc. Wellbutrin SR
release tablets, USP tablets
150 mg (twice-a-day
dosing)
Demeclocycline HCl Impax Laboratories Inc. Declomycin HCl
tablets, USP 150 tablets
mg and 300 mg
Nitrofurantoin Mylan Pharmaceuticals Macrobid
(monohydrate/ Inc. capsules
macrocrystals)
capsules 100 mg
Bupropion HCl extended- Impax Laboratories Inc. Wellbutrin SR
release tablets, USP sustained-
150 mg (twice-a-day release tablets
dosing)
Nifedipine extended- Martec Scientific Inc. Procardia XL90
release tablets, mg
USP 90 mg
Oxycodone HCl extended- Endo Pharmaceuticals Oxycontin
release tablets 10 mg, Inc. extended-release
20 mg and 40 mg tablets
Oxycodone HCl extended- Teva Pharmaceuticals Oxycontin
release tablets 80 mg USA extended-release
tablets
Erythromycin and Atrix Laboratories Inc. Benzamycin
benzoyl peroxide topical gel
topical gel, USP 3%/5%
Miconazole nitrate L. Perrigo Co. Monistat 3
cream 4% and miconazole combination pack
nitrate cream 2% 4%/2%
(combination package)
(O-T-C)
Quinapril HCl and Amide Pharmaceutical Accuretic tablets
hydro-chlorothiazide Inc.
tablets 10 mg (base)/
12.5 mg, 20 mg (base)/
12.5 mg and 20 mg
(base)/25 mg
APRIL
Terconazole vaginal Taro Pharmaceuticals Terazol 3 vaginal
cream 0.8% USA Inc. cream
Ribavirin capsules Three Rivers Rebetol capsules
200 mg Pharmaceuticals LLC
Ribavirin capsules Sandoz Inc. Rebetrol capsules
200 mg
Norethindrone and Barr Laboratories Inc. Ovcon-35 (28-day
ethinyl estradiol cycle)
tablets, USP 0.4 mg/
0.035 mg; 28-day cycle
(balziva-28 tablets)
Norethindrone and Barr Laboratories Inc. Ovcon-35 tablets
ethinyl estradiol
tablets, USP 0.4 mg/
0.035 mg; 21-day cycle
(balziva-21 tablets)
Mirtazapine tablets 7.5 Caraco Pharmaceutical Remeron tablets
mg, 15 mg, 30 mg and 45 Laboratories Ltd.
mg
Terbutaline sulfate Bedford Laboratories Brethine injection
injection, USP 1 mg/ml
Theophylline extended- Able Laboratories Inc. Uniphyl tablets
release tablets 400 mg
Theophyllineextended- Able Laboratories Inc. Uniphyl tablets
release tablets 600 mg
Gabapentin tablets 100 Ivax Pharmaceuticals Neurontin
mg, 300 mg and 400 mg Inc. capsules (100 mg)
and tablets
Fludarabine phosphate Sicor Pharmaceuticals Fludara for
injection 25 mg/ml; Inc. injection
packaged in 50 mg/2 ml
single-dose vials
MAY
Propoxyphene napsylate Vintage Pharmaceuticals Darvocet-n 100
and acetaminophen Inc.
tablets, USP 100
mg/325 mg
Ofloxacin ophthalmic Hi-Tech Pharmacal Co. Ocuflox
solution, USP 0.3% ophthalmic
solution
Fluticasone propionate Altana Inc. Cutivate cream
cream 0.05%
Fluticasone propionate Clay-Park Labs Inc. Cutivate cream
cream 0.05%
Fluticasone propionate Clay-Park Labs Inc. Cutivate ointment
ointment 0.005%
Fluticasone propionate Atrix Laboratories Inc. Cutivate cream
cream 0.05%
Fluticasone propionate Altana Inc. Cutivate ointment
ointment 0.005%
Ofloxacin ophthalmic Bausch & Lomb Ocuflox
solution, USP 0.3% ophthalmic
solution
Ofloxacin ophthalmic Alcon Inc. Ocuflox
solution, USP 0.3% ophthalmic
solution
Clarithromycin tablets, Roxane Laboratories Biaxin filmtab
USP 250 mg and 500 mg Inc.
Bupropion HCl extended- Impax Laboratories Inc. Zyban sustained-
release tablets 150 mg release tablets
(RLD = Zyban/GSK)
Itraconazole capsules Eon Labs Inc. Sporanox
100 mg capsules
Metronidazol etopical Altana Inc. Metrocream
cream 0.75% topical cream
JUNE
Ciprofloxacin tablets, Eon Labs Inc. Cipro tablets
USP 250 mg, 500 mg and
750 mg
Ciprofloxacin tablets, Mylan Pharmaceuticals Cipro tablets
USP 250 mg, 500 mg and Inc.
750 mg
Ciprofloxacin tablets, Carlsbad Cipro tablets
USP 250 mg, 500 mg and Technology Inc.
750 mg
Ciprofloxacin Novex Pharma Ciloxan
ophthalmic solution, ophthalmic
USP 0.3% solution
Ciprofloxacin tablets, Sandoz Inc. Cipro tablets
USP 250 mg, 500 mg and
750 mg
Ciprofloxacin tablets, Cobalt Pharmaceuticals Cipro tablets
USP 250 mg, 500 mg and Inc.
750 mg
Ciprofloxacin Bausch & Lomb Ciloxan
ophthalmic solution, ophthalmic
USP 0.3% solution
Ciprofloxacin tablets, Barr Laboratories Inc. Cipro tablets
USP 250 mg, 500 mg and
750 mg
Ciprofloxacin tablets, Hikma Pharmaceuticals Cipro tablets
USP 250 mg, 500 mg and
750 mg
Ciprofloxacin tablets, Dr. Reddy’s Cipro tablets
USP 100 mg, 250 mg, 500 Laboratories Ltd.
mg and 750 mg
Ciprofloxacin tablets, Ranbaxy Laboratories Cipro tablets
USP 250 mg, 500 mg and Ltd.
750 mg
Ciprofloxacin tablets, Martec Scientific Inc. Cipro tablets
USP 250 mg, 500 mg and
750 mg
Ciprofloxacin tablets, Ivax Pharmaceuticals Cipro tablets
USP 250 mg, 500 mg and Inc.
750 mg
Ciprofloxacin tablets, Genpharm Inc. Cipro tablets
USP 250 mg, 500 mg and
750 mg
Ciprofloxacin tablets, Teva Pharmaceuticals Cipro tablets
USP 250 mg, 500 mg and USA
750 mg
Adenosine injection, Sicor Pharmaceuticals Adenocard
USP 3 mg/ml; packaged Inc. injection
in 6 mg/2 ml and 12 mg/
4 ml single-dose vials
Adenosine injection, Bedford Laboratories Adenocard
USP 3 mg/ml; packaged injection
in 6 mg/2 ml and 12 mg/
4 ml single-dose vials
Adenosine injection, Baxter Healthcare Corp. Adenocard
USP 3 mg/ml; packaged injection
in 6 mg/2 ml single-
dose vials
Adenosine injection, Baxter Healthcare Corp. Adenocard
USP 3 mg/ml; packaged injection
in 6 mg/2 ml single-
dose syringes
Levothyroxinesodium Mylan Pharmaceuticals Synthroid tablets
tablets, USP 0.025 mg, Inc.
0.05 mg, 0.075 mg,
0.088 mg, 0.1 mg, 0.112
mg, 0.125 mg, 0.15 mg,
0.175 mg, 0.2 mg and
0.3 mg
Clarithromycin Andrx Pharmaceuticals Biaxin XL filmtabs
extended-release LLC
tablets 500 mg
Albuterol sulfate Nephron Pharmaceuticals Accuneb
inhalation solution Corp. inhalation
0.042% (base) solution
JULY
Promethazine HCl Able Laboratories Inc. Phenergan
tablets, USP 12.5 tablets
mg, 25 mg and 50 mg
Glycolax (polyethylene Schwarz Pharma Inc. Miralax powder
glycol 3350 powder for for oral solution
oral solution)
Piperacillin for Istituto Biochimico Pipracil for
injection, USP 40 g/ Italiano SPA injection
vial (pharmacy bulk
package)
Levothyroxinesodium Mylan Pharmaceuticals Levoxyl tablets
tablets, USP 0.025 mg, Inc.
0.05 mg, 0.075 mg,
0.088 mg, 0.1 mg,
0.112 mg 0.125 mg, 0.15
mg, 0.175 mg, 0.2 mg
and 0.3 mg are
AB-rated to Levoxyl
tablets of Jones
Pharma Inc.
Clotrimazole and Taro Pharmaceuticals Lotrisone lotion
betamethasone USA Inc.
dipropionate lotion
1%/0.05% (base)
Medroxyprogesterone Sicor Pharmaceuticals Depo-Provera
acetate injectable Inc. injectable
suspension, USP 150 mg/ suspension
1 ml single-dose vials
Fluconazole tablets 50 Sandoz Inc. Diflucan tablets
mg, 100 mg, 150 mg and
200 mg
Fluconazole for oral Ranbaxy Laboratories Diflucan for oral
suspension 10 mg/ml Ltd. suspension
(50 mg/5 ml) and 40
mg/ml (200 mg/5 ml)
Fluconazole tablets Mylan Pharmaceuticals Diflucan tablets
50 mg, 100 mg, 150 mg Inc.
and 200 mg
Fluconazolefororal Roxane Diflucan for oral
suspension 10 mg/ml Laboratories Inc. suspension
(50 mg/5 ml) and 40
mg/ml (200 mg/5 ml)
Fluconazole injection Sicor Pharmaceuticals Diflucan (in 0.9%
(in 0.9% sodium Inc. sodium chloride
chloride injection) injection)
2 mg/ml; packaged in
200 mg/100 ml and 400
mg/200 ml single-dose
vials
Fluconazole tablets Novopharm Ltd. Diflucan tablets
50 mg, 100 mg, 150 mg
and 200 mg
Fluconazole tablets Apotex Inc. Diflucan tablets
50 mg, 100 mg, 150 mg
and 200 mg
Fluconazole injection Bedford Laboratories Diflucan injection
(in 0.9% sodium (in 0.9% sodium
chloride injection) chloride I
2 mg/ml; packaged in
200 mg/100 ml and 400
mg/200 ml single-dose
vials
Fluconazole tablets 50 Pliva Inc. Diflucan tablets
mg, 100 mg, 150 mg and
200 mg
Fluconazole tablets 50 Ranbaxy Laboratories Diflucan tablets
mg, 100 mg, 150 mg and Ltd.
200 mg
Fluconazole tablets 50 Taro Pharmaceutical Diflucan tablets
mg, 100 mg, 150 mg and Industries Ltd.
200 mg
Fluconazole injection American Pharmaceutical Diflucan injection
(in 0.9% sodium Partners Inc. (in 0.9% sodium
chloride injection) chloride)
2 mg/ml; packaged in
200 mg/100 ml and 400
mg/200 ml single-dose
vials
Nicotine polacrilex Watson Laboratories Nicorette mint
gum, USP (mint Inc.
flavored) (O-T-C)
2 mg (base)
Fluconazole tablets 50 Roxane Laboratories Diflucan tablets
mg, 100 mg, 150 mg and Inc.
200 mg
Fluconazole tablets 50 Gedeon Richter Ltd. Diflucan tablets
mg, 100 mg, 150 mg and
200 mg
Fluconazole tablets 50 Genpharm Inc. Diflucan tablets
mg, 100 mg, 150 mg and
200 mg
Fluconazole tablets 50 Ivax Pharmaceuticals Diflucan tablets
mg, 100 mg, 150 mg and Inc.
200 mg
Fluconazole tablets 50 Dr. Reddy’s Diflucan tablets
mg, 100 mg, 150 mg and Laboratories Ltd.
200 mg
Fluconazole injection Baxter Healthcare Corp. Diflucan injection
(in 0.9% sodium (in 0.9% sodium
chloride injection) chloride)
2 mg/ml; packaged in
200 mg/100 ml and 400
mg/200 ml single-dose
plastic containers
Fluconazole injection Hospira Inc. Diflucan injection
(in 0.9% sodium (in 0.9% sodium
chloride injection) chloride)
2 mg/ml; packaged in
200 mg/100 ml and 400
mg/200 ml single-dose
plastic containers
Fluconazole injection Hospira Inc. Diflucan injection
(in 5% dextrose (in dextrose 5%
injection) 2 mg/ml; injection)
packaged in 200 mg/100
ml and 400 mg/200 ml
single-dose plastic
containers
Clotrimazole lozenges, Roxane Laboratories Mycelex Troche
USP 10 mg Inc.
Alclometasone Taro Pharmaceuticals Aclovate ointment
dipropionate ointment, USA Inc.
USP 0.05%
Nicotine polacrilex Watson Laboratories Nicorette gum
gum, USP (mint-flavor) Inc. (mint)
(O-T-C) 4 mg (base)
Fluconazole injection Mayne Pharma (USA) Inc. Diflucan injection
(in 0.9% sodium (in 0.9% sodium
chloride injection) chloride)
2 mg/ml; packaged in
200 mg/100 ml and 400
mg/200 ml single-dose
plastic containers
AUGUST
Ciclopiroxtopical Altana Inc. Loproxtopical
suspension USP, 0.77% suspension,
(lotion) 0.77% 0.77%
Levocarnitine oral Lyne Laboratories Inc. Carnitor oral
solution, USP 1 g/10 ml solution
Esmolol HCl injection Bedford Laboratories Brevibloc
10 mg/ml; packaged in injection
100 mg/10 ml single-
dose vials
Metoprolol tartrate and Mylan Pharmaceuticals Lopressor HCT
hydro-chlorothiazide Inc. tablets
tablets, USP 50 mg/25
mg, 100 mg/25 mg and
100 mg/50 mg
Allopurinol sodium Bedford Laboratories Aloprim for
forinjection 500 mg injection
(base)/vial
Carbidopa and levodopa Schwarz Pharma Inc. Sinemet tablets
orally disintegrating
tablets 10 mg/100 mg,
25 mg/100 mg and 25 mg/
250 mg
SEPTEMBER
Ergotamine tartrate and West-Ward Ercatab tablets
caffeine tablets, USP 1 Pharmaceutical Corp.
mg/100 mg
Cyclosporin oral Morton Grove Sandimmune
solution, USP 100 mg/ml Pharmaceuticals Inc. oral solution
Mesalamine rectal Agis Industries Rowasa rectal
suspension, USP (1983) Ltd. suspension
(enema) 4 g/60 ml (enema)
Levocarnitine tablets, Corepharma LLC Carnitor tablets
USP 330 mg
Dexrazoxane for Bedford Laboratories Zinecard for
injection 250 mg and injection
500 mg; packaged in
single-dose vials
Norethindrone and Barr Laboratories Inc. Tri-Norinyl
ethinyl estradiol tablets
tablets, USP 0.5 mg/
0.035 mg and 1 mg/0.035
mg (28-day regimen)
(aranelle tablets)
OCTOBER
Flumazenil injection Sicor Pharmaceuticals Romazicon
0.1 mg/ml; packaged in Inc. injection
0.5 mg/5 ml and 1 mg/
10 ml multiple-dose
vials
Flumazenil injection Bedford Laboratories Romazicon
0.1 mg/ml; packaged in injection
0.5 mg/5 ml and 1 mg/10
ml multiple-dose vials
Flumazenil injection Baxter Healthcare Corp. Romazicon
0.1 mg/ml; packaged in injection
0.5 mg/5 ml and 1 mg/10
ml multiple-dose vials
Flumazenil injection Apotex Corp. Romazicon
0.1 mg/ml; packaged in injection
0.5 mg/5 ml and 1 mg/10
ml multiple-dose vials
Flumazenil injection American Pharmaceutical Romazicon
0.1 mg/ml; packaged in Partners Inc. injection
0.5 mg/5 ml and 1 mg/10
ml multiple-dose vials
Carboplatin for American Pharmaceutical Paraplatin for
injection, USP 50 mg, Partners Inc. injection
150 mg and 450 mg
single-dose vials
Carboplatin for Bedford Laboratories Paraplatin for
injection, USP 50 mg, injection
150 mg and 450 mg
single-dose vials
Carboplatin for Pharmachemie BV Paraplatin for
injection, USP 50 mg, injection
150 mg and 450 mg
single-dose vials
Metformin HCl extended- Barr Laboratories Inc. Glucophage XR
release tablets 750 mg extended-release
tablets
Carboplatin injection Pharmachemie BV Paraplatin
10 mg/ml; packaged in injection
50 mg/5 ml, 150 mg/15 (aqueous)
ml and 450 mg/45 ml
multiple-dose vials.
Carboplatin injection Mayne Pharma (USA) Inc. Paraplatin
10 mg/ml; packaged in injection
50 mg/5 ml, 150 mg/15 (aqueous)
ml and 450 mg/45 ml
single-dose vials
Levofloxacin tablets Mylan Pharmaceuticals Levaquin tablets
250 mg and 500 mg Inc.
Gabapentin tablets 600 Purepac Pharmaceutical Neurontin tablets
mg and 800 mg Co.
Citalopram hydrobromide Eon Labs Inc. Celexa tablets
tablets 10 mg (base),
20 mg (base) and 40 mg
(base)
Citalopram hydrobromide Aurobindo Pharma Ltd. Celexa tablets
tablets 10 mg (base),
20 mg (base) and 40 mg
(base)
Citalopram hydrobromide Purepac Pharmaceutical Celexa tablets
tablets 10 mg (base), Co.
20 mg (base) and 40 mg
(base)
Citalopram hydrobromide Dr. Reddy’s Celexa tablets
tablets 10 mg (base), Laboratories Ltd.
20 mg (base) and 40 mg
(base)
Citalopram hydrobromide Corepharma LLC Celexa tablets
tablets 10 mg (base),
20 mg (base) and 40 mg
(base)
NOVEMBER
Felodipine extended- Mutual Pharmaceutical Plendil extended-
release tablets, USP Co. Inc. release tablets
2.5 mg, 5 mg and 10 mg
Sodium tetradecyl Bioniche Pharma USA Sotradecol
sulfate injection 1% Inc. injection
(10 mg/ml) and 3%
(30 mg/ml) packaged
in 2 ml vials
Pilocarpine HCl Corepharma LLC Salagen tablets
tablets 5mg
Ranitidine injection, Bedford Laboratories Zantac injection
USP 25 mg (base)/ml;
packaged in 50 mg
(base)/2 ml and 150
mg (base)/6 ml
multiple-dose vials
Carboplatin injection Mayne Pharma (USA) Inc. Paraplatin
10 mg/ml; packaged in injection
600 mg/60 ml single- (aqueous)
dose vials
Cilostazol tablets 100 Eon Labs Inc. Pletal tablets
mg
Cilostazol tablets 100 Corepharma LLC Pletal tablets
mg
Cilostazol tablets 50 Alphapharm Pty. Ltd. Pletal tablets
mg and 100 mg
DECEMBER
Fosinopril sodium and Andrx Pharmaceuticals Monopril HCT
hydrochlorothiazide LLC tablets
tablets 10 mg/12.5 mg
and 20 mg/12.5 mg
Bupropion HCl extended- Impax Laboratories Inc. Wellbutrin SR
release tablets, USP sustained-
200 mg release tablets
Didanosine delayed- Barr Laboratories Inc. Videx EC delayed-
release capsules 200 release capsules
mg, 250 mg and 400 mg
Citalopram hydrobromide Roxane Laboratories Celexa oral
oral solution 10 mg Inc. solution
(base)/5 ml
Quinapril tablets, USP Ranbaxy Laboratories Accupril tablets
5 mg, 10 mg, 20 mg and Ltd.
40 mg
Halobetasol propionate Taro Pharmaceuticals Ultravate
ointment 0.05% USA Inc. ointment
Halobetasol propionate Altana Inc. Ultravate cream
cream 0.05%
Halobetasol propionate Altana Inc. Ultravate
ointment 0.05% ointment
Halobetasol propionate Agis Industries Ultravate
ointment 0.05% (1983) Ltd. ointment
Halobetasol propionate Agis Industries Ultravate cream
cream 0.05% (1983) Ltd.
Mometasone furoate Taro Pharmaceuticals Elocon cream
cream, USP 0.1% USA Inc.
Glycopyrrolate tablets, Corepharma LLC Robinul tablets 1
USP 1 mg and 2 mg mg and robinul
forte tablets
Clindamycin phosphate Altana Inc. Cleocin vaginal
vaginal cream, USP 2% cream
(base)
Hydrocortisone butyrate Taro Pharmaceutical Locoid ointment
ointment, USP 0.1% Industries Ltd.
Ciclopiroxolamine Altanalnc. Loprox cream
cream, USP 0.77%
FDA/Center for Drug Evaluation and Research
COPYRIGHT 2005 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning
