Details for New Drug Application (NDA): 214305
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The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for 214305
Tradename: | BUTALBITAL AND ACETAMINOPHEN |
Applicant: | Quagen |
Ingredient: | acetaminophen; butalbital |
Patents: | 0 |
Suppliers and Packaging for NDA: 214305
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 214305 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-147 | 70752-147-10 | 100 TABLET in 1 BOTTLE, PLASTIC (70752-147-10) |
BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 214305 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-147 | 70752-147-14 | 500 TABLET in 1 BOTTLE, PLASTIC (70752-147-14) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG;50MG | ||||
Approval Date: | Feb 1, 2024 | TE: | AA | RLD: | No |
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