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Serving leading biopharmaceutical companies globally:

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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083426

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NDA 083426 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, Ani Pharms, and Hi-tech Pharma Co, and is included in eighty-seven NDAs. It is available from sixty-six 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. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for 083426

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 083426

Ingredient-typePhenothiazines

Suppliers and Packaging for NDA: 083426

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 083426 ANDA Watson Laboratories, Inc. 0591-5307 0591-5307-10 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5307-10)
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 083426 ANDA Watson Laboratories, Inc. 0591-5307 0591-5307-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5307-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Deloitte
Fish and Richardson
UBS
Mallinckrodt
AstraZeneca
McKesson
Federal Trade Commission
Merck

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