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Generated: April 24, 2019

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Details for New Drug Application (NDA): 087953

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NDA 087953 describes PROMETHAZINE PLAIN, which is a drug marketed by Wockhardt Bio Ag and is included in one NDA. It is available from five suppliers. Additional details are available on the PROMETHAZINE PLAIN profile page.

The generic ingredient in PROMETHAZINE PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
Summary for 087953
Applicant:Wockhardt Bio Ag
Ingredient:promethazine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 087953
Medical Subject Heading (MeSH) Categories for 087953
Suppliers and Packaging for NDA: 087953
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE PLAIN promethazine hydrochloride SYRUP;ORAL 087953 ANDA Atlantic Biologicals Corps 17856-0608 17856-0608-5 5 mL in 1 CUP (17856-0608-5)
PROMETHAZINE PLAIN promethazine hydrochloride SYRUP;ORAL 087953 ANDA Rebel Distributors Corp 21695-703 21695-703-04 118 mL in 1 BOTTLE (21695-703-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength6.25MG/5ML
Approval Date:Nov 15, 1982TE:AARLD:No

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