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Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040454

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NDA 040454 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Perrigo New York, Watson Labs, Taro, Ivax Sub Teva Pharms, Able, Teva, West-ward Pharms Int, Kvk Tech, Impax Labs, Pvt Form, Luitpold, Pharm Assoc, Abbott, Prinston Inc, Bedford Labs, Hi Tech Pharma, Tablicaps, G And W Labs, Sandoz, X-gen Pharms, Hospira, Vintage, Lannett, Teva Pharms Usa, Mylan, Sun Pharm Inds, Akorn, Marsam Pharms Llc, Sun Pharm Inds Inc, Mylan Institutional, Heritage Pharma, Tris Pharma Inc, Watson Labs Inc, Amneal Pharms Ny, Amneal Pharms, Wockhardt, Kv Pharm, Nostrum Labs Inc, Whiteworth Town Plsn, 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-four 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. Eight suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for NDA: 040454

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

Pharmacology for NDA: 040454

Ingredient-typePhenothiazines

Suppliers and Packaging for NDA: 040454

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
INJECTABLE;INJECTION 040454 ANDA Physicians Total Care, Inc. 54868-0262 54868-0262-1 25 VIAL in 1 CARTON (54868-0262-1) > 1 mL in 1 VIAL
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
INJECTABLE;INJECTION 040454 ANDA Cardinal Health 55154-0455 55154-0455-5 5 VIAL in 1 BAG (55154-0455-5) > 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 22, 2002TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 22, 2002TE:RLD:No


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