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Results For "tentative-approval"

257 News Found

Granules India receives ANDA approval for Gabapentin Tablets
Drug Approval | March 30, 2023

Granules India receives ANDA approval for Gabapentin Tablets

Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults


Alembic receives USFDA final approval for Prazosin Hydrochloride Capsules
Drug Approval | March 09, 2023

Alembic receives USFDA final approval for Prazosin Hydrochloride Capsules

Prazosin Hydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure


Eugia Pharma receives USFDA approval for Lenalidomide Capsules
Drug Approval | March 09, 2023

Eugia Pharma receives USFDA approval for Lenalidomide Capsules

The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone


Alembic Pharmaceuticals gets USFDA final approval for fluorouracil injection
Drug Approval | March 07, 2023

Alembic Pharmaceuticals gets USFDA final approval for fluorouracil injection

Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum and breast


Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg
Drug Approval | February 27, 2023

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.


Briefs: Neuland Laboratories, Cipla and Zydus
Drug Approval | February 20, 2023

Briefs: Neuland Laboratories, Cipla and Zydus

Cipla has received 8 inspectional observations in Form 483


Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules
News | February 11, 2023

Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product


Sun Pharma Q3 FY23 Gross Sales up 13.1%; Net profit up 5.2%
News | February 01, 2023

Sun Pharma Q3 FY23 Gross Sales up 13.1%; Net profit up 5.2%

India formulation sales at Rs. 3,391.9 crore, up 7.1% over Q3 last year


Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules
Drug Approval | January 25, 2023

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA