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Details for New Drug Application (NDA): 083401

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NDA 083401 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Perrigo New York, Watson Labs, Taro, Ivax Sub Teva Pharms, Able, Teva, Eurohlth Intl Sarl, Kvk Tech, Impax Labs, Pvt Form, Luitpold, Pharm Assoc, Abbott, Vintage Pharms, Bedford Labs, Hi Tech Pharma, Tablicaps, G And W Labs, Sandoz, X-gen Pharms, Hospira, Vintage, Lannett, Teva Pharms Usa, Mylan, Sun Pharm Inds, Akorn, Marsam Pharms Llc, Sun Pharm Inds Inc, Mylan Institutional, Heritage Pharma, Tris Pharma Inc, Watson Labs Inc, Amneal Pharms Ny, Amneal Pharms, Wockhardt, Kv Pharm, Nostrum Labs Inc, Whiteworth Town Plsn, Zydus Pharms Usa, Actavis Mid Atlantic, Ani Pharms, and Hi-tech Pharma Co, and is included in eighty-eight NDAs. It is available from sixty-three suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for NDA: 083401

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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