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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 040593


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NDA 040593 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Hikma, Wockhardt Bio Ag, and Ani Pharms, and is included in ninety NDAs. It is available from fifty-one 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. Three suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040593
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:Sandoz
Ingredient:promethazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040593

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Nov 8, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Nov 8, 2006TE:RLD:No

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