Details for New Drug Application (NDA): 085381
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NDA 085381 describes BUTICAPS, which is a drug marketed by Medpointe Pharm Hlc and is included in one NDA. Additional details are available on the BUTICAPS profile page.
The generic ingredient in BUTICAPS is butabarbital sodium. There are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.
The generic ingredient in BUTICAPS is butabarbital sodium. There are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.
Summary for 085381
| Tradename: | BUTICAPS |
| Applicant: | Medpointe Pharm Hlc |
| Ingredient: | butabarbital sodium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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