| Product |
Company |
Generic name |
KEGG DRUG |
|
Rosuvastatin calcium tablet, film coated 10 mg (ANDA)
|
Proficient Rx LP |
Rosuvastatin Calcium |
D01915
|
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 2 g0mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 4 g/20mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 3 g5mL (ANDA)
|
Fresenius Kabi USA, LLC |
Piperacillin and Tazobactam |
D02505
|
Lamotrigine tablet, orally disintegrating 25 mg (ANDA)
Lamotrigine tablet, orally disintegrating 50 mg (ANDA)
Lamotrigine tablet, orally disintegrating 100 mg (ANDA)
Lamotrigine tablet, orally disintegrating 200 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
Lamotrigine |
D00354
|
|
KETOROLAC TROMETHAMINE tablet 10 mg (ANDA)
|
ATNAHS PHARMA US LIMITED |
KETOROLAC TROMETHAMINE |
D00813
|
|
ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) kit (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution |
D08745
|
|
Acetylcysteine injection, solution 200 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Acetylcysteine |
D00221
|
|
Acetylcysteine solution 200 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
ACETYLCYSTEINE |
D00221
|
Imipenem and Cilastatin injection, powder, for solution 500 mg/20mL (ANDA)
Imipenem and Cilastatin injection, powder, for solution 250 mg/20mL (ANDA)
|
Fresenius Kabi USA, LLC |
Imipenem and Cilastatin Sodium |
D00344
|
|
Acetylcysteine injection, solution 200 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Acetylcysteine |
D00221
|
|
Amoxicillin capsule 500 mg (ANDA)
|
Asclemed USA, Inc. |
Amoxicillin |
D00229
|
|
TRAMADOL HYDROCHLORIDE tablet, extended release 200 mg (ANDA)
|
Proficient Rx LP |
TRAMADOL HYDROCHLORIDE |
D01355
|
Eszopiclone tablet, film coated 1 mg (ANDA)
Eszopiclone tablet, film coated 2 mg (ANDA)
Eszopiclone tablet, film coated 3 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Eszopiclone |
D02624
|
|
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic solution 188 mg/63mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) |
D02955
|
Eszopiclone tablet, film coated 1 mg (ANDA)
Eszopiclone tablet, film coated 2 mg (ANDA)
Eszopiclone tablet, film coated 3 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
eszopiclone |
D02624
|
|
Spironolactone tablet, film coated 25 mg (ANDA)
|
Proficient Rx LP |
spironolactone |
D00443
|
|
ATORVASTATIN CALCIUM tablet, film coated 80 mg (ANDA)
|
Proficient Rx LP |
ATORVASTATIN CALCIUM |
D02258
|
|
Oxycodone and Acetaminophen tablet 325 mg (ANDA)
|
Proficient Rx LP |
Oxycodone and Acetaminophen |
D02153
|
|
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic solution 105 mg/35mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution |
D02955
|
|
CPDA-1 solution 17.3 mg/63mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Solution |
D02954
|
|
Ciprofloxacin HCl Ophthalmic solution 3 mg/mL (ANDA)
|
Altaire Pharmaceuticals Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
Candesartan Cilexetil and Hydrochlorothiazide tablet 16 mg (ANDA)
Candesartan Cilexetil and Hydrochlorothiazide tablet 32 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Candesartan Cilexetil and Hydrochlorothiazide |
D09196
|
|
Ofloxacin ophthalmic solution 3 mg/mL (ANDA)
|
Altaire Pharmaceuticals Inc. |
Ofloxacin |
D00453
|
Isotretinoin capsule, liquid filled 10 mg (ANDA)
Isotretinoin capsule, liquid filled 20 mg (ANDA)
Isotretinoin capsule, liquid filled 30 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Isotretinoin |
D00348
|
|
Daptomycin injection, powder, lyophilized, for solution 500 mg0mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
Daptomycin |
D01080
|
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 2 g0mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 4 g/20mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 3 g5mL (ANDA)
|
Fresenius Kabi USA, LLC |
Piperacillin and Tazobactam |
D02505
|
|
Benzonatate capsule 200 mg (ANDA)
|
Proficient Rx LP |
Benzonatate |
D00242
|
Sertraline tablet, film coated 50 mg (ANDA)
Sertraline tablet, film coated 100 mg (ANDA)
Sertraline tablet, film coated 25 mg (ANDA)
|
Proficient Rx LP |
Sertraline |
D00825
|
TREANDA injection, powder, lyophilized, for solution 25 mg/5mL (NDA)
TREANDA injection, powder, lyophilized, for solution 100 mg/20mL (NDA)
|
Cephalon, LLC |
Bendamustine Hydrochloride |
D07085
|
|
Sumatriptan Succinate injection 6 mg/.5mL (ANDA)
|
Dr. Reddy's Laboratories Limited |
Sumatriptan Succinate |
D00676
|
Bisoprolol Fumarate tablet 5 mg (ANDA)
Bisoprolol Fumarate tablet 10 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc. |
Bisoprolol fumarate |
D00634
|
|
Sodium Chloride injection, solution 3 g00mL (ANDA)
|
Fresenius Kabi USA, LLC |
Sodium Chloride |
D02056
|
Penicillin V Potassium tablet, film coated 250 mg (ANDA)
Penicillin V Potassium tablet, film coated 500 mg (ANDA)
|
Rising Health, LLC |
Penicillin V Potassium |
D00497
|
Warfarin Sodium tablet 1 mg (ANDA)
Warfarin Sodium tablet 2 mg (ANDA)
Warfarin Sodium tablet 2.5 mg (ANDA)
Warfarin Sodium tablet 3 mg (ANDA)
Warfarin Sodium tablet 4 mg (ANDA)
Warfarin Sodium tablet 5 mg (ANDA)
|
Proficient Rx LP |
warfarin sodium |
D00564
|
|
Levocetirizine Dihydrochloride tablet 5 mg (ANDA)
|
Proficient Rx LP |
Levocetirizine Dihydrochloride |
D08118
|
|
Trazodone Hydrochloride tablet 300 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Trazodone Hydrochloride |
D00820
|
Albuterol Sulfate solution .63 mg/3mL (ANDA)
Albuterol Sulfate solution 1.25 mg/3mL (ANDA)
|
Mylan Pharmaceuticals Inc. |
Albuterol Sulfate |
D00683
|
|
Hydrocodone Bitartrate and Acetaminophen solution 325 mg5mL (ANDA)
|
Eywa Pharma Inc |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
|
Sterile Water injection, solution 1000 mL000mL (ANDA)
|
Fresenius Kabi USA, LLC |
Water |
D00001
|
|
Dacarbazine injection, powder, for solution 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
DACARBAZINE |
D00288
|
|
LIDOCAINE HYDROCHLORIDE injection 10 mg/mL (ANDA)
|
B. Braun Medical Inc. |
LIDOCAINE HYDROCHLORIDE |
D02086
|