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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040026

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NDA 040026 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-two 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 NDA: 040026

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

Pharmacology for NDA: 040026

Ingredient-typePhenothiazines

Suppliers and Packaging for NDA: 040026

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
SYRUP;ORAL 040026 ANDA Hi-Tech Pharmacal Co., Inc. 50383-801 50383-801-04 118 mL in 1 BOTTLE (50383-801-04)
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
SYRUP;ORAL 040026 ANDA Hi-Tech Pharmacal Co., Inc. 50383-801 50383-801-08 237 mL in 1 BOTTLE (50383-801-08)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength6.25MG/5ML
Approval Date:Sep 25, 1998TE:AARLD:No


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