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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040479

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NDA 040479 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 040479

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

Pharmacology for NDA: 040479

Ingredient-typePhenothiazines

Suppliers and Packaging for NDA: 040479

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040479 ANDA Paddock Laboratories, Inc. 0574-7234 0574-7234-12 12 PACKET in 1 BOX (0574-7234-12) > 1 SUPPOSITORY in 1 PACKET
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040479 ANDA Paddock Laboratories, Inc. 0574-7236 0574-7236-12 12 PACKET in 1 BOX (0574-7236-12) > 1 SUPPOSITORY in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength12.5MG
Approval Date:Jun 24, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength25MG
Approval Date:Jun 24, 2003TE:ABRLD:No


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Deloitte
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QuintilesIMS

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