Tag: ANDA

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brivaracetam...

Picture: Pixabay Granules India announced that the US Food & Drug Administration (USFDA) has granted final approval for...

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 Pharmaceuticals announced that it has received approval of an additional strength of 500 mg to its Abbreviated New Drug Application (ANDA),...

Strides Pharma Science has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Singapore, has received approval for oxybutynin chloride...

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual...

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9%...

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) metolazone tablets...

Granules India has announced that its a wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc (GPI), received the US Food & Drug Administration...

Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food &...

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...

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 Laboratories announced the launch of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL), Multiple-Dose Vials a therapeutic equivalent generic...

Natco Pharma announced that its marketing partner, Breckenridge Pharmaceutical, has received final approval for its Abbreviated New Drug Application (ANDA) for Pomalidomide...

Amneal Pharmaceuticals has received approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA) for Acyclovir...

Alembic Pharma announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...

Zydus Cadila has received tentative approval from the USFDA to market Dapagliflozin Tablets, 5 mg and 10 mg (US RLD: Farxiga Tablets)....

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA)...

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...

Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug...

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate...

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...

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 Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Sirolimus Tablets, 0.5 mg, 1...