| Product |
Company |
Generic name |
KEGG DRUG |
|
ALBUTEROL SULFATE inhalant 90 ug (ANDA)
|
Civica Inc.
|
albuterol sulfate
|
D00683
|
|
Haloperidol injection, solution 5 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC
|
HALOPERIDOL LACTATE
|
D08035
|
|
Sodium Chloride injection, solution 9 mg/mL (NDA)
|
B. Braun Medical Inc.
|
Sodium Chloride
|
D02056
|
Dexmethylphenidate Hydrochloride capsule, extended release 5 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 10 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 15 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 20 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 30 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 40 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 25 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 35 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Dexmethylphenidate Hydrochloride
|
D03721
|
|
Aloprim injection, powder, lyophilized, for solution 500 mg/25mL (NDA)
|
Mylan Institutional LLC
|
Allopurinol
|
D07564
|
|
Rizatriptan Benzoate tablet, orally disintegrating 5 mg (ANDA)
|
Quality Care Products, LLC
|
Rizatriptan Benzoate
|
D00675
|
|
Sotalol Hydrochloride tablet 80 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Sotalol Hydrochloride
|
D01026
|
|
Fulvestrant injection 50 mg/mL (ANDA)
|
Sandoz Inc
|
Fulvestrant
|
D01161
|
|
LISINOPRIL tablet 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Lisinopril
|
D00362
|
|
GLYCOPYRROLATE solution .2 mg/mL (ANDA)
|
Somerset Therapeutics, LLC
|
GLYCOPYRROLATE
|
D00540
|
|
Furosemide tablet 40 mg (ANDA)
|
Lake Erie Medical DBA Quality Care Products LLC
|
Furosemide
|
D00331
|
|
Terbinafine tablet 250 mg (ANDA)
|
Aurobindo Pharma Limited
|
Terbinafine Hydrochloride
|
D02219
|
|
Methyltestosterone capsule 10 mg (ANDA)
|
Novitium Pharma LLC
|
Methyltestosterone
|
D00408
|
|
Folic Acid injection, solution 5 mg/mL (ANDA)
|
XGen Pharmaceuticals DJB, Inc.
|
Folic Acid
|
D00070
|
Naropin injection, solution 2 mg/mL (NDA)
Naropin injection, solution 5 mg/mL (NDA)
|
Fresenius Kabi USA, LLC
|
ROPIVACAINE HYDROCHLORIDE
|
D04048
|
|
Balanced Salt solution .48 mg/mL (ANDA)
|
B. Braun Medical Inc.
|
Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate
|
|
Sunitinib malate capsule 12.5 mg (ANDA)
Sunitinib malate capsule 25 mg (ANDA)
Sunitinib malate capsule 37.5 mg (ANDA)
Sunitinib malate capsule 50 mg (ANDA)
|
NorthStar RxLLC
|
Sunitinib malate
|
D06402
|
|
OCTREOSCAN kit (NDA)
|
Curium US LLC
|
Indium In -111 Pentetreotide
|
D02108
|
|
Levetiracetam injection, solution 100 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC
|
LEVETIRACETAM
|
D00709
|
Timoptic in Ocudose solution 3.4 mg/mL (NDA)
Timoptic in Ocudose solution 6.8 mg/mL (NDA)
|
Bausch & Lomb Incorporated
|
Timolol Maleate
|
D00603
|
|
Zolpidem tablet 5 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Zolpidem Tartrate
|
D00706
|
|
CIPROFLOXACIN tablet, coated 250 mg (ANDA)
|
Direct Rx
|
CIPROFLOXACIN
|
D02216
|
|
Nystatin Oral Suspension solution 100000 [USP'U]/mL (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Nystatin Oral Suspension
|
D00202
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 325 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Hydrocodone Bitartrate and Acetaminophen
|
D00846
|
LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet 12.5 mg (ANDA)
LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet 25 mg (ANDA)
|
Lake Erie Medical DBA Quality Care Products LLC
|
LISINOPRIL AND HYDROCHLOROTHIAZIDE
|
D10268
|
|
Clotrimazole and Betamethasone Dipropionate cream .5 mg/g (ANDA)
|
Lake Erie Medical DBA Quality Care Products LLC
|
Clotrimazole and Betamethasone Dipropionate
|
D10300
|
Penicillin V Potassium tablet, film coated 250 mg (ANDA)
Penicillin V Potassium tablet, film coated 500 mg (ANDA)
|
Aurobindo Pharma Limited
|
Penicillin V Potassium
|
D00497
|
|
Timolol Maleate solution 6.8 mg/mL (NDA AUTHORIZED GENERIC)
|
Bausch & Lomb Americas Inc.
|
Timolol Maleate
|
D00603
|
Orapred ODT tablet, orally disintegrating 10 mg (NDA)
Orapred ODT tablet, orally disintegrating 15 mg (NDA)
Orapred ODT tablet, orally disintegrating 30 mg (NDA)
|
Concordia Pharmaceuticals Inc.
|
prednisolone sodium phosphate
|
D00981
|
|
Ibuprofen and famotidine tablet, film coated 26.6 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Ibuprofen and famotidine
|
D11575
|
meloxicam tablet 7.5 mg (ANDA)
meloxicam tablet 15 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc.
|
meloxicam
|
D00969
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 7.5 mg (ANDA)
|
SA3, LLC
|
Cyclobenzaprine Hydrochloride
|
D00772
|
Prednisolone Sodium Phosphate ODT tablet, orally disintegrating 10 mg (NDA AUTHORIZED GENERIC)
Prednisolone Sodium Phosphate ODT tablet, orally disintegrating 15 mg (NDA AUTHORIZED GENERIC)
Prednisolone Sodium Phosphate tablet, orally disintegrating 30 mg (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories
|
prednisolone sodium phosphate
|
D00981
|
Ibuprofen tablet 400 mg (ANDA)
Ibuprofen tablet 600 mg (ANDA)
Ibuprofen tablet 800 mg (ANDA)
|
MARKSANS PHARMA LIMITED
|
Ibuprofen
|
D00126
|
|
Dorzolamide Hydrochloride and Timolol Maleate solution 20 mg/mL (ANDA)
|
Sandoz Inc
|
Dorzolamide Hydrochloride and Timolol Maleate
|
D08493
|
|
Sodium Chloride injection, solution, concentrate 4 meq/mL (ANDA)
|
Fresenius Kabi USA, LLC
|
Sodium Chloride
|
D02056
|
|
Gatifloxacin solution/ drops 5 mg/mL (ANDA)
|
Sandoz Inc
|
gatifloxacin
|
D00589
|
|
NICARDIPINE HYDROCHLORIDE injection, solution 25 mg0mL (ANDA)
|
AuroMedics Pharma LLC
|
NICARDIPINE HYDROCHLORIDE
|
D00617
|
|
Cromolyn Sodium solution/ drops 40 mg/mL (ANDA)
|
Sandoz Inc
|
Cromolyn Sodium
|
D00526
|
|
Neomycin and Polymyxin B Sulfates and Dexamethasone suspension 1 mg/mL (ANDA)
|
Sandoz Inc.
|
neomycin sulfate, polymyxin b sulfate and dexamethasone
|
D11177
|