Details for New Drug Application (NDA): 080763
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NDA 080763 describes HYDRAMINE, which is a drug marketed by Alpharma Us Pharms and is included in two NDAs. Additional details are available on the HYDRAMINE profile page.
The generic ingredient in HYDRAMINE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
The generic ingredient in HYDRAMINE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
Summary for 080763
| Tradename: | HYDRAMINE |
| Applicant: | Alpharma Us Pharms |
| Ingredient: | diphenhydramine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 080763
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | ELIXIR;ORAL | Strength | 12.5MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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