Details for New Drug Application (NDA): 200243
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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-three suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 200243
Tradename: | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
Applicant: | Lannett Co Inc |
Ingredient: | acetaminophen; butalbital; caffeine |
Patents: | 0 |
Pharmacology for NDA: 200243
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 200243
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | TABLET;ORAL | 200243 | ANDA | Lannett Company, Inc. | 0527-1695 | 0527-1695-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0527-1695-01) |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | TABLET;ORAL | 200243 | ANDA | Lannett Company, Inc. | 0527-1695 | 0527-1695-05 | 500 TABLET in 1 BOTTLE, PLASTIC (0527-1695-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;50MG;40MG | ||||
Approval Date: | Sep 13, 2012 | TE: | AA | RLD: | No |
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