Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 24

Results For "Abbreviated-New-Drug-Application"

287 News Found

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


Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets
Drug Approval | March 21, 2022

Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets

The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older


Jubilant Pharmova arm receives ANDA approval for psychoneurosis drug
Drug Approval | March 19, 2022

Jubilant Pharmova arm receives ANDA approval for psychoneurosis drug

The generic version of Sinequan, which is used for the treatment of anxiety, depression, and other target symptoms of psychoneurosis


Alembic receives USFDA tentative approval for hypertension drug
Drug Approval | March 14, 2022

Alembic receives USFDA tentative approval for hypertension drug

Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA


USFDA approves Lupin’s Vigabatrin oral solution
Drug Approval | March 11, 2022

USFDA approves Lupin’s Vigabatrin oral solution

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


Aleor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone Acetonide ointment
Drug Approval | March 08, 2022

Aleor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone Acetonide ointment

Nystatin and Triamcinolone Acetonide ointment is indicated for the treatment of cutaneous candidiasis


Lupin receives USFDA approval for topical solution
Drug Approval | March 03, 2022

Lupin receives USFDA approval for topical solution

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