Details for New Drug Application (NDA): 050056
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NDA 050056 describes PRINCIPEN '500', which is a drug marketed by Apothecon and is included in two NDAs. Additional details are available on the PRINCIPEN '500' profile page.
The generic ingredient in PRINCIPEN '500' is ampicillin/ampicillin trihydrate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.
The generic ingredient in PRINCIPEN '500' is ampicillin/ampicillin trihydrate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.
Summary for 050056
| Tradename: | PRINCIPEN '500' |
| Applicant: | Apothecon |
| Ingredient: | ampicillin/ampicillin trihydrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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