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Generated: October 16, 2018

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Details for New Drug Application (NDA): 080629

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NDA 080629 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Akorn, Bedford Labs, Hospira, Luitpold, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, X-gen Pharms, Able, G And W Labs, Perrigo New York, Taro, Watson Labs Inc, Amneal Pharms, Hi Tech Pharma, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, Vintage, Whiteworth Town Plsn, Amneal Pharms Ny, Heritage Pharma, Impax Labs, Ivax Sub Teva Pharms, Kvk Tech, Lannett, Mylan, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, Ani Pharms, and Hi-tech Pharma Co, and is included in eighty-seven NDAs. It is available from sixty-eight 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. Four suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 080629
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:Watson Labs
Ingredient:promethazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 080629

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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