Details for New Drug Application (NDA): 085953
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NDA 085953 describes PROMETH PLAIN, which is a drug marketed by Actavis Mid Atlantic and is included in one NDA. Additional details are available on the PROMETH PLAIN profile page.
The generic ingredient in PROMETH PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
The generic ingredient in PROMETH PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
Summary for 085953
| Tradename: | PROMETH PLAIN |
| Applicant: | Actavis Mid Atlantic |
| Ingredient: | promethazine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 085953
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 6.25MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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