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Results For "reference-listed-drug"

194 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


Eugia Pharma receives USFDA Approval for Icatibant Injection
Drug Approval | August 16, 2023

Eugia Pharma receives USFDA Approval for Icatibant Injection

This is the 166th ANDA out of Eugia Pharma Speciality Group facilities


Eugia Pharma receives USFDA approval for Vancomycin Hydrochloride for Injection USP
Drug Approval | August 06, 2023

Eugia Pharma receives USFDA approval for Vancomycin Hydrochloride for Injection USP

The product is being launched in August 2023


Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation
Drug Approval | August 03, 2023

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation

Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.


Eugia Pharma receives USFDA approval for Plerixafor Injection
Drug Approval | July 26, 2023

Eugia Pharma receives USFDA approval for Plerixafor Injection

The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023


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


Lupin launches Thiamine Hydrochloride Injection USP in the US
Drug Approval | June 19, 2023

Lupin launches Thiamine Hydrochloride Injection USP in the US

Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.


Granules India receives ANDA approval for Levetiracetam Tablets
Drug Approval | June 15, 2023

Granules India receives ANDA approval for Levetiracetam Tablets

Granules now has a total of 58 ANDA approvals from US FDA