Thursday, October 28, 2021
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Caplin Steriles gets USFDA nod for generic Argatroban injection

Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food...

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),...

Lupin gets USFDA nod for Rufinamide Oral Suspension

Lupin announced it has received approval for its Rufinamide Oral Suspension, 40 mg/mL, from the United States Food and Drug Administration (USFDA),...

Lupin gets USFDA marketing nod for generic Welchol tablets

Pharma major Lupin Limited (Lupin) has received approval for its colesevelam hydrochloride tablets, 625 mg, from the United States Food and Drug...

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...

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...

Lupin gets USFDA approval for Penicillamine tablets

Pharma major Lupin Limited has received approval from the United States Food and Drug Administration (FDA) to market for penicillamine tablets USP,...

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...

USFDA approves first C-19 test kit for home use

The U.S. Food and Drug Administration said on Tuesday it had approved the first C-19 self-testing kit for home use that provides results within 30...

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...

Glenmark gets USFDA nod for generic Prograf capsules

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for tacrolimus capsules...

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 Linagliptin Tablets

Zydus Cadila has received tentative approval from the USFDA to market Linagliptin Tablets, 5 mg (US RLD: Tradjenta Tablets).

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)...

Zydus Cadila gets USFDA nod to market Albuterol tablets

Zydus Cadila has received final approval from the US Food & Drug Administration (FDA) to market albuterol tablets in the strengths of...

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...

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