Details for New Drug Application (NDA): 008381
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The generic ingredient in PROMETHAZINE HYDROCHLORIDE PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
Summary for 008381
Tradename: | PROMETHAZINE HYDROCHLORIDE PLAIN |
Applicant: | Ani Pharms |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 008381
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Apr 18, 1984 | TE: | RLD: | Yes |
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