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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040596

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NDA 040596 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 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 040596
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:Zydus Pharms Usa
Ingredient:promethazine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040596
Ingredient-typePhenothiazines
Medical Subject Heading (MeSH) Categories for 040596
Suppliers and Packaging for NDA: 040596
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040596 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1539 N 0615-1539-31
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040596 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1539 N 0615-1539-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Nov 18, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 18, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Nov 18, 2005TE:ABRLD:No

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