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Last Updated: September 25, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040500


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NDA 040500 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Akorn, Am Regent, Bedford Labs, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, Xgen Pharms, Able, Cosette, Perrigo Israel, Taro, Watson Labs Inc, Amneal Pharms, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Impax Labs, Invatech, 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, and Ani Pharms, and is included in eighty-nine NDAs. It is available from forty-nine 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 040500
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:Perrigo Israel
Ingredient:promethazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040500
Medical Subject Heading (MeSH) Categories for 040500
Suppliers and Packaging for NDA: 040500
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040500 ANDA PD-Rx Pharmaceuticals, Inc. 43063-060 43063-060-02 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-02)
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040500 ANDA PD-Rx Pharmaceuticals, Inc. 43063-060 43063-060-04 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength12.5MG
Approval Date:Jun 30, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength25MG
Approval Date:Jun 30, 2003TE:ABRLD:No

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