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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040428

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NDA 040428 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: 040428

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

Pharmacology for NDA: 040428

Ingredient-typePhenothiazines

Suppliers and Packaging for NDA: 040428

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
SUPPOSITORY;RECTAL 040428 ANDA Actavis Pharma, Inc. 0591-2985 0591-2985-39 12 PACKET in 1 BOX (0591-2985-39) > 1 SUPPOSITORY in 1 PACKET
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
SUPPOSITORY;RECTAL 040428 ANDA Actavis Pharma, Inc. 0591-2992 0591-2992-39 12 PACKET in 1 BOX (0591-2992-39) > 1 SUPPOSITORY in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength25MG
Approval Date:Feb 5, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength12.5MG
Approval Date:Mar 31, 2003TE:ABRLD:No


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Colorcon
QuintilesIMS
Covington
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Fuji
AstraZeneca
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Cerilliant
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