Details for New Drug Application (NDA): 214288
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The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 214288
Tradename: | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
Applicant: | Quagen |
Ingredient: | acetaminophen; butalbital; caffeine |
Patents: | 0 |
Pharmacology for NDA: 214288
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 214288
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 214288 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-144 | 70752-144-10 | 100 CAPSULE in 1 BOTTLE, PLASTIC (70752-144-10) |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 214288 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-144 | 70752-144-14 | 500 CAPSULE in 1 BOTTLE, PLASTIC (70752-144-14) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG;50MG;40MG | ||||
Approval Date: | Feb 8, 2024 | TE: | AA | RLD: | No |
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