Details for New Drug Application (NDA): 089987
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NDA 089987 describes BUTAPAP, which is a drug marketed by Mikart and is included in two NDAs. It is available from two suppliers. Additional details are available on the BUTAPAP profile page.
The generic ingredient in BUTAPAP is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
The generic ingredient in BUTAPAP is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for 089987
| Tradename: | BUTAPAP |
| Applicant: | Mikart |
| Ingredient: | acetaminophen; butalbital |
| Patents: | 0 |
Suppliers and Packaging for NDA: 089987
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTAPAP | acetaminophen; butalbital | TABLET;ORAL | 089987 | ANDA | Par Pharmaceutical | 0603-2540 | 0603-2540-21 | 100 TABLET in 1 BOTTLE (0603-2540-21) |
| BUTAPAP | acetaminophen; butalbital | TABLET;ORAL | 089987 | ANDA | El Dorado Distributors LLC | 11584-0030 | 11584-0030-1 | 100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;50MG | ||||
| Approval Date: | Oct 26, 1992 | TE: | AA | RLD: | No | ||||
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