Unichem Labs get tentative ANDA approval from USFDA
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Unichem Labs get tentative ANDA approval from USFDA

Agency News

Mumbai, May 7: Unichem Laboratories Limited has received tentative ANDA approval from USFDA for some formulations.

The approved medicines include Unichem's Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 5 mg/120 mg (OTC) to market a generic version of Johnson and Johnson Consumer Inc's Zyrtec-D 12 Hour Extended Tablets.

Unichem's Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 5 mg/120 mg (OTC) are indicated for Antihistamine and Nasal decongestant. The Product will be commercialised from Unichem's Goa Plant on receipt of final approval. (UNI)

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