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Results For "New-Drug-Application"

341 News Found

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)


NATCO files generic Erdafitinib Tablets in USA
Drug Approval | July 26, 2023

NATCO files generic Erdafitinib Tablets in USA

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma


Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
Drug Approval | July 24, 2023

Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

This product would be manufactured at Lupin's Nagpur facility in India


Lupin receives approval from USFDA for Chlorpromazine Hydrochloride Tablets USP
Drug Approval | July 14, 2023

Lupin receives approval from USFDA for Chlorpromazine Hydrochloride Tablets USP

Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.


Granules India announces approval for Acetaminophen and Ibuprofen Tablets
Drug Approval | July 14, 2023

Granules India announces approval for Acetaminophen and Ibuprofen Tablets

This product will be launched through Granules Consumer Health (GCH) division