Details for New Drug Application (NDA): 010841
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NDA 010841 describes PEGANONE, which is a drug marketed by Recordati Rare and is included in one NDA. Additional details are available on the PEGANONE profile page.
The generic ingredient in PEGANONE is ethotoin. There is one drug master file entry for this compound. Additional details are available on the ethotoin profile page.
The generic ingredient in PEGANONE is ethotoin. There is one drug master file entry for this compound. Additional details are available on the ethotoin profile page.
Summary for 010841
| Tradename: | PEGANONE |
| Applicant: | Recordati Rare |
| Ingredient: | ethotoin |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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