Details for New Drug Application (NDA): 061394
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NDA 061394 describes PRINCIPEN, which is a drug marketed by Apothecon and Bristol Myers Squibb and is included in nine NDAs. Additional details are available on the PRINCIPEN profile page.
The generic ingredient in PRINCIPEN is ampicillin/ampicillin trihydrate; probenecid. Additional details are available on the ampicillin/ampicillin trihydrate; probenecid profile page.
The generic ingredient in PRINCIPEN is ampicillin/ampicillin trihydrate; probenecid. Additional details are available on the ampicillin/ampicillin trihydrate; probenecid profile page.
Summary for 061394
| Tradename: | PRINCIPEN |
| Applicant: | Apothecon |
| Ingredient: | ampicillin/ampicillin trihydrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 100MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 125MG BASE/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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