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Results For "Abbreviated-New-Drug-Application"

233 News Found

Caplin gets USFDA approval for Sumatriptan
News | July 15, 2021

Caplin gets USFDA approval for Sumatriptan

Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache


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


Cipla receives final approval for generic version of Brovana
News | June 24, 2021

Cipla receives final approval for generic version of Brovana

Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana


Sun Pharma settles patent litigation for Revlimid
News | June 23, 2021

Sun Pharma settles patent litigation for Revlimid

Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain generic lenalidomide capsules


Sun Pharma’s US Specialty business to grow at 21% CAGR in 2 years
News | June 14, 2021

Sun Pharma’s US Specialty business to grow at 21% CAGR in 2 years

The company expects to see steady performance led by new launches and gradual normalization post the scale-up in vaccination


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


Caplin Steriles gets USFDA approval
News | April 23, 2021

Caplin Steriles gets USFDA approval

The injection comes in multiple formats


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