Details for New Drug Application (NDA): 213321
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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-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 213321
Tradename: | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
Applicant: | Granules |
Ingredient: | acetaminophen; butalbital; caffeine |
Patents: | 0 |
Pharmacology for NDA: 213321
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 213321
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 213321 | ANDA | Granules Pharmaceuticals Inc. | 70010-044 | 70010-044-01 | 100 CAPSULE in 1 BOTTLE (70010-044-01) |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 213321 | ANDA | Granules Pharmaceuticals Inc. | 70010-044 | 70010-044-05 | 500 CAPSULE in 1 BOTTLE (70010-044-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG;50MG;40MG | ||||
Approval Date: | Apr 8, 2020 | TE: | AA | RLD: | No |
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