Details for New Drug Application (NDA): 050520
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NDA 050520 describes SPECTROBID, which is a drug marketed by Pfizer and is included in two NDAs. Additional details are available on the SPECTROBID profile page.
The generic ingredient in SPECTROBID is bacampicillin hydrochloride. There are two drug master file entries for this compound. Additional details are available on the bacampicillin hydrochloride profile page.
The generic ingredient in SPECTROBID is bacampicillin hydrochloride. There are two drug master file entries for this compound. Additional details are available on the bacampicillin hydrochloride profile page.
Summary for 050520
| Tradename: | SPECTROBID |
| Applicant: | Pfizer |
| Ingredient: | bacampicillin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| 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 | 800MG | ||||
| Approval Date: | Sep 12, 1983 | TE: | RLD: | No | |||||
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