Product |
Company |
Generic name |
KEGG DRUG |
Metronidazole tablet 250 mg (ANDA)
|
Bryant Ranch Prepack
|
Metronidazole
|
D00409
|
Lidocaine Hydrochloride solution 20 mg/mL (ANDA)
|
ATLANTIC BIOLOGICALS CORP.
|
Lidocaine Hydrochloride
|
D02086
|
Sevelamer Carbonate tablet, film coated 800 mg (ANDA)
|
Proficient Rx LP
|
Sevelamer Carbonate
|
D06642
|
Glucotrol XL tablet, extended release 5 mg (NDA)
Glucotrol XL tablet, extended release 10 mg (NDA)
|
Roerig
|
glipizide
|
D00335
|
Sterile Water irrigant 100 mL00mL (NDA)
|
Baxter Healthcare Corporation
|
Water
|
D00001
|
Dorzolamide Hydrochloride and Timolol Maleate solution/ drops 20 mg/mL (ANDA)
|
Gland Pharma Limited
|
Dorzolamide Hydrochloride and Timolol Maleate
|
D08493
|
Suprane liquid 240 mL/240mL (NDA)
|
Baxter Healthcare Corporation
|
DESFLURANE
|
D00546
|
celecoxib capsule 100 mg (ANDA)
|
Quality Care Products LLC
|
celecoxib
|
D00567
|
Escitalopram tablet, film coated 20 mg (ANDA)
|
QPharma Inc
|
Escitalopram
|
D02567
|
Buspirone HCL tablet 10 mg (ANDA)
|
Direct_Rx
|
Buspirone HCL
|
D00702
|
Amlodipine besylate tablet 10 mg (ANDA)
|
Bryant Ranch Prepack
|
Amlodipine besylate
|
D00615
|
Doxycycline Hyclate capsule 100 mg (ANDA)
|
Bryant Ranch Prepack
|
Doxycycline
|
D02129
|
Hydromorphone Hydrochloride injection, solution 1 mg/mL (NDA)
Hydromorphone Hydrochloride injection, solution 2 mg/mL (NDA)
Hydromorphone Hydrochloride injection, solution .5 mg/.5mL (NDA)
Hydromorphone Hydrochloride injection, solution .25 mg/.5mL (NDA)
|
Hospira, Inc.
|
HYDROMORPHONE HYDROCHLORIDE
|
D00839
|
PENBRAYA kit (BLA)
|
Pfizer Laboratories Div Pfizer Inc
|
meningococcal groups a, b, c, w, and y vaccine
|
D12436
|
oxycodone hydrochloride solution 5 mg/5mL (ANDA)
|
ATLANTIC BIOLOGICALS CORP.
|
oxycodone hydrochloride
|
D00847
|
Oxcarbazepine tablet, film coated 300 mg (ANDA)
|
REMEDYREPACK INC.
|
oxcarbazepine
|
D00533
|
Lamotrigine tablet, extended release 50 mg (ANDA)
|
Proficient Rx LP
|
Lamotrigine
|
D00354
|
bisoprolol fumarate and hydrochlorothiazide tablet 10 mg (ANDA)
|
REMEDYREPACK INC.
|
bisoprolol fumarate and hydrochlorothiazide
|
D10275
|
Glipizide tablet 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc..
|
Glipizide
|
D00335
|
Norgestimate and ethinyl estradiol kit (ANDA)
|
Naari Pte Limited
|
Norgestimate and ethinyl estradiol
|
D10590
|
Lidocaine Hydrochloride injection, solution 10 mg/mL (ANDA)
|
Henry Schein, Inc.
|
Lidocaine Hydrochloride Anhydrous
|
D08127
|
Estradiol gel .25 mg/.25g (ANDA)
Estradiol gel .5 mg/.5g (ANDA)
Estradiol gel .75 mg/.75g (ANDA)
Estradiol gel 1 mg/g (ANDA)
Estradiol gel 1.25 mg.25g (ANDA)
|
NorthStar Rx LLC
|
Estradiol
|
D00105
|
Fluoxetine tablet, film coated 60 mg (ANDA)
|
Bryant Ranch Prepack
|
Fluoxetine
|
D00823
|
prednisone tablet 5 mg (ANDA)
|
QPharma Inc
|
PREDNISONE
|
D00473
|
ALBUTEROL SULFATE solution .83 mg/mL (ANDA)
|
Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.
|
ALBUTEROL SULFATE
|
D00683
|
XYLOCAINE MPF injection, solution 10 mg/mL (NDA)
|
HF Acquisition Co LLC, DBA HealthFirst
|
XYLOCAINE MPF
|
D02086
|
Ionosol MB and Dextrose injection, solution 5 g00mL (NDA)
|
ICU Medical Inc.
|
DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
|
|
ibuprofen tablet 400 mg (ANDA)
ibuprofen tablet 600 mg (ANDA)
ibuprofen tablet 800 mg (ANDA)
|
SKYA HEALTH, LLC
|
ibuprofen
|
D00126
|
Irbesartan tablet 75 mg (ANDA)
Irbesartan tablet 150 mg (ANDA)
Irbesartan tablet 300 mg (ANDA)
|
Aurobindo Pharma Limited
|
Irbesartan
|
D00523
|
Amoxicillin tablet, film coated 875 mg (ANDA)
|
QPharma Inc
|
Amoxicillin
|
D00229
|
Amoxicillin and Clavulanate Potassium powder, for suspension 400 mg/5mL (ANDA)
|
A-S Medication Solutions
|
Amoxicillin and Clavulanate Potassium
|
D06485
|
ESTRADIOL VALERATE injection, solution 20 mg/mL (ANDA)
ESTRADIOL VALERATE injection, solution 40 mg/mL (ANDA)
|
American Regent, Inc.
|
ESTRADIOL VALERATE
|
D01413
|
BUPROPION HYDROCHLORIDE tablet, film coated, extended release 450 mg (NDA AUTHORIZED GENERIC)
|
Wockhardt USA LLC.
|
bupropion hydrochloride
|
D00817
|
Eptifibatide injection, solution 2 mg/mL (ANDA)
Eptifibatide injection, solution .75 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc.
|
Eptifibatide
|
D06888
|
ACYCLOVIR capsule 200 mg (ANDA)
|
Apotex Corp.
|
ACYCLOVIR
|
D00222
|
Glipizide tablet 10 mg (ANDA)
|
Preferred Pharmaceuticals, Inc.
|
Glipizide
|
D00335
|
Metoclopramide injection 5 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
|
Metoclopramide Hydrochloride
|
D05008
|
Glipizide tablet, film coated, extended release 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Glipizide
|
D00335
|
Lisinopril tablet 5 mg (ANDA)
|
Bryant Ranch Prepack
|
Lisinopril
|
D00362
|
Atomoxetine Hydrochloride capsule 25 mg (ANDA)
|
Bryant Ranch Prepack
|
atomoxetine hydrochloride
|
D02574
|