Details for New Drug Application (NDA): 010348
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NDA 010348 describes SPARINE, which is a drug marketed by Wyeth Ayerst and Hikma and is included in three NDAs. Additional details are available on the SPARINE profile page.
The generic ingredient in SPARINE is promazine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the promazine hydrochloride profile page.
The generic ingredient in SPARINE is promazine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the promazine hydrochloride profile page.
Summary for 010348
| Tradename: | SPARINE |
| Applicant: | Wyeth Ayerst |
| Ingredient: | promazine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 010348
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 | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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