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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040785

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NDA 040785 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. Five suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040785
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:Wockhardt
Ingredient:promethazine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040785
Ingredient-typePhenothiazines
Medical Subject Heading (MeSH) Categories for 040785
Suppliers and Packaging for NDA: 040785
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 040785 ANDA Wockhardt USA LLC. 64679-760 N 64679-760-01
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 040785 ANDA Wockhardt USA LLC. 64679-760 N 64679-760-02

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Sep 26, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Sep 26, 2008TE:RLD:No

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