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Results For "tentative-approval"

251 News Found

Alembic announces USFDA approval for Desipramine Hydrochloride Tablets
News | July 09, 2021

Alembic announces USFDA approval for Desipramine Hydrochloride Tablets

The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA


Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets
News | July 01, 2021

Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets

TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg


Zydus Cadila receives USFDA approval for Fingolimod capsules
News | June 25, 2021

Zydus Cadila receives USFDA approval for Fingolimod capsules

Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis


Sun Pharma Q4 FY21 net profit up 124%
News | May 27, 2021

Sun Pharma Q4 FY21 net profit up 124%

The company reported net profit for FY21 at Rs. 2,903.8 crore, lower by 23% over last year


NATCO Pharma receives USFDA approval for Lenalidomide capsules
Policy | May 24, 2021

NATCO Pharma receives USFDA approval for Lenalidomide capsules

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.


Alembic gets USFDA approval for Lurasidone Hydrochloride tablets
News | May 15, 2021

Alembic gets USFDA approval for Lurasidone Hydrochloride tablets

Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder


Alembic announces USFDA approval for two drugs
News | May 06, 2021

Alembic announces USFDA approval for two drugs

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA


NATCO receives approval for Ibrutinib tablets from ANDA
News | April 11, 2021

NATCO receives approval for Ibrutinib tablets from ANDA

The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths


Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets
News | February 25, 2021

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets

ranules now has a total of 38 ANDA approvals from US FDA.


Granules India announces approval of Potassium Chloride ER Capsules
News | February 18, 2021

Granules India announces approval of Potassium Chloride ER Capsules

Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).