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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 040596


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NDA 040596 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Hikma, Wockhardt Bio Ag, and Ani Pharms, and is included in ninety NDAs. It is available from fifty-one 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. Three 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 040596
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, LLC dba Vangard Labs 0615-8154 0615-8154-39 30 TABLET in 1 BLISTER PACK (0615-8154-39)
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040596 ANDA A-S Medication Solutions 50090-4812 50090-4812-0 90 TABLET in 1 BOTTLE (50090-4812-0)

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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