Tag: ANDA
Granules India gets USFDA nod of Metformin HCL ER Tablets
Picture: Pixabay
Granules India announced that the US Food & Drug Administration (USFDA) has granted final approval for...
JB Chemicals gets USFDA nod for drug to treat Pollen allergy
NEW DELHI: JB Chemicals and Pharmaceuticals on Friday said it has received approval from the US health regulator to market Loratadine tablets, used to treat allergies, in...
Amneal gets USFDA nod for Generic Abiraterone Acetate Tablets
Amneal Pharmaceuticals announced that it has received approval of an additional strength of 500 mg to its Abbreviated New Drug Application (ANDA),...
Strides gets USFDA nod for Oxybutynin Chloride tablets
Strides Pharma Science has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Singapore, has received approval for oxybutynin chloride...
Alembic gets USFDA approval for Asenapine Sublingual Tablets
Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual...
Aurobindo gets USFDA nod for sedative injection
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9%...
Alembic gets USFDA approval for Zaroxolyn tablets
Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) metolazone tablets...
Granules India gets USFDA approval for Penicillamine capsules
Granules India has announced that its a wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc (GPI), received the US Food & Drug Administration...
Aleor gets USFDA approval for generic AndroGel
Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food &...
Strides Pharma gets USFDA nod for Prednisone tablets
Strides Pharma Science Ltd on Monday said it has received approval from the US health regulator for its generic version of Prednisone tablets, prescribed for a...
Pfizer moves US court against Aurobindo, Dr Reddy’s on cancer drug
HYDERABAD: Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug...
Dr Reddy’s: Succinylcholine Chloride Inj launched
Dr Reddy’s Laboratories announced the launch of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL), Multiple-Dose Vials a therapeutic equivalent generic...
USFDA approves Pomalidomide capsules for Natco
Natco Pharma announced that its marketing partner, Breckenridge Pharmaceutical, has received final approval for its Abbreviated New Drug Application (ANDA) for Pomalidomide...
USFDA approval to Amneal for Acyclovir Cream
Amneal Pharmaceuticals has received approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA) for Acyclovir...
Alembic gets USFDA tentative nod for Palbociclib Capsules
Alembic Pharma announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...
Zydus Cadila gets tentative USFDA approval for Dapagliflozin Tablets
Zydus Cadila has received tentative approval from the USFDA to market Dapagliflozin Tablets, 5 mg and 10 mg (US RLD: Farxiga Tablets)....
Alembic Pharma gets USFDA approval for Timolol Maleate
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA)...
Aurobindo Pharma gets USFDA nod for pain treatment injection
New Delhi: Drug firm Aurobindo Pharma on Thursday said it has received final approval from the US health regulator for its generic Acetaminophen injection, used...
Aleor gets USFDA nod for Tavaborole topical solution
Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug...
Alembic gets USFDA nod for Fenofibrate Capsules
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate...
Strides receives USFDA nod for Ethacrynic Acid Tablets
Strides Pharma Science Limited on Tuesday announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Ltd, Singapore, has received approval for Ethacrynic Acid...
Zydus Cadila gets USFDA nod for bladder treatment drug
Drug firm Zydus Cadila on Tuesday said it has received final approval from the US health regulator to market Solifenacin Succinate tablets, used for treatment of...
Glenmark receives USFDA nod for Sirolimus tablets
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Sirolimus Tablets, 0.5 mg, 1...
Zydus Cadila gets tentative USFDA nod for Tofacitinib ER tablets
Zydus Cadila has received tentative approval from the USFDA to market Tofacitinib Extended-Release Tablets, 11 mg (US RLD: Xeljanz XR Tablets).