Details for New Drug Application (NDA): 083997
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NDA 083997 describes ZIPAN-50, which is a drug marketed by Altana and is included in one NDA. Additional details are available on the ZIPAN-50 profile page.
The generic ingredient in ZIPAN-50 is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
The generic ingredient in ZIPAN-50 is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
Summary for 083997
| Tradename: | ZIPAN-50 |
| Applicant: | Altana |
| Ingredient: | promethazine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 083997
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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