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US Army
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083312

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NDA 083312 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 fifty-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. Three suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 083312
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:promethazine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 083312
Ingredient-typePhenothiazines
Medical Subject Heading (MeSH) Categories for 083312
Suppliers and Packaging for NDA: 083312
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 083312 ANDA West-ward Pharmaceutical Corp. 0641-0928 N 0641-0928-25
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 083312 ANDA West-ward Pharmaceutical Corp. 0641-0929 N 0641-0929-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Harvard Business School
Cerilliant
Cipla
Argus Health
Baxter
Mallinckrodt
Moodys
McKesson

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