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Unichem Laboratories receives approval from USFDA for hydrocloride tablets

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On 07 May 2019

Unichem Laboratories Limited announced that it received tentative ANDA approval from USFDA for 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 (Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride, 5mg/120 mg) Extended Tablets. These are indicated for antihistamine and nasal decongestant. The Product will be commercialized from Unichemls Goa Plant on receipt of final approval.

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First Published: Tue, May 07 2019. 12:21 IST
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