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Results For "Abbreviated-New-Drug-Application"

233 News Found

Lupin receives USFDA approval for Pregabalin and Iloperidone
Drug Approval | May 06, 2022

Lupin receives USFDA approval for Pregabalin and Iloperidone

While Pregabalin will be manufactured at the Aurangabad facility, Iloperidone will be manufactured at the Goa facility


Aleor Dermaceuticals receives USFDA approval for Docosanol Cream
Drug Approval | May 04, 2022

Aleor Dermaceuticals receives USFDA approval for Docosanol Cream

Docosanol Cream, 10% (OTC) has an estimated market size of US$60 million for twelve months ending December 2021 according to IQVIA


Aleor Dermaceuticals receives USFDA approval for Clobestasol
Drug Approval | April 25, 2022

Aleor Dermaceuticals receives USFDA approval for Clobestasol

Clobetasol Propionate Foam, 0.05% has an estimated market size of US $ IO million for twelve months ending Dec 2021 according to IQVIA


Alembic Pharmaceuticals receives USFDA tentative approval for heart failure drug
Drug Approval | April 20, 2022

Alembic Pharmaceuticals receives USFDA tentative approval for heart failure drug

Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA


Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets
Drug Approval | April 18, 2022

Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India


Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg
Drug Approval | April 15, 2022

Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg

The product will be manufactured at Lupin’s facility in Goa, India


Zydus to supply Sagent's caffeine citrate oral solution from Jarod
Biotech | April 13, 2022

Zydus to supply Sagent's caffeine citrate oral solution from Jarod

This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants


Aleor receives USFDA approval for Lidocaine and Prilocaine Cream
Drug Approval | April 12, 2022

Aleor receives USFDA approval for Lidocaine and Prilocaine Cream

Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA


Alembic gets USFDA tentative approval for dabigatran etexilate capsules
Drug Approval | April 07, 2022

Alembic gets USFDA tentative approval for dabigatran etexilate capsules

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim


Lupin receives approval from USFDA for Sildenafil for Oral Suspension
Drug Approval | March 24, 2022

Lupin receives approval from USFDA for Sildenafil for Oral Suspension

The product will be manufactured at Lupin’s facility in Goa, India