Details for New Drug Application (NDA): 085146
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The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 085146
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Invatech |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 085146
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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