Details for New Drug Application (NDA): 214291
NDA 214291 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Dr Reddys Labs Sa, Granules, Alvogen, Halsey, Lgm Pharma, Ne Rx Pharma, Pharmazone, Pharmobedient, Quagen, and Watson Labs, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the BUTALBITAL AND ACETAMINOPHEN profile page.
The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for 214291
| Tradename: | BUTALBITAL AND ACETAMINOPHEN |
| Applicant: | Quagen |
| Ingredient: | acetaminophen; butalbital |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214291
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 214291 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-148 | 70752-148-10 | 100 TABLET in 1 BOTTLE (70752-148-10) |
| BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 214291 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-148 | 70752-148-14 | 500 TABLET in 1 BOTTLE (70752-148-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;50MG | ||||
| Approval Date: | Jan 18, 2024 | TE: | AA | RLD: | No | ||||
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