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Results For "Abbreviated-New-Drug-Application"

233 News Found

Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


Lupin receives USFDA approval for Pirfenidone Capsules
Drug Approval | August 31, 2023

Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US


Lupin receives approval from USFDA for Pirfenidone Tablets
Drug Approval | August 28, 2023

Lupin receives approval from USFDA for Pirfenidone Tablets

This product will be manufactured at Lupin's Pithampur facility in India


Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals
Drug Approval | August 24, 2023

Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals

The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat


Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets
News | August 23, 2023

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets

Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


Lupin receives approval from USFDA for Bromfenac Ophthalmic
News | August 20, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).


Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP
Drug Approval | August 16, 2023

Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).


Lupin receives USFDA approval for fluocinolone acetonide body oil
Drug Approval | August 09, 2023

Lupin receives USFDA approval for fluocinolone acetonide body oil

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)


Lupin receives approval from US FDA for Turqoz
Drug Approval | August 02, 2023

Lupin receives approval from US FDA for Turqoz

Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)