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Details for New Drug Application (NDA): 203484
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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 203484
Tradename: | BUTALBITAL AND ACETAMINOPHEN |
Applicant: | Larken Labs Inc |
Ingredient: | acetaminophen; butalbital |
Patents: | 0 |
Suppliers and Packaging for NDA: 203484
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALLZITAL | acetaminophen; butalbital | TABLET;ORAL | 203484 | ANDA | Larken Laboratories, Inc. | 68047-721 | 68047-721-01 | 100 TABLET in 1 BOTTLE (68047-721-01) |
ALLZITAL | acetaminophen; butalbital | TABLET;ORAL | 203484 | ANDA | Larken Laboratories, Inc. | 68047-721 | 68047-721-30 | 30 TABLET in 1 BOTTLE (68047-721-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;25MG | ||||
Approval Date: | Dec 4, 2015 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;50MG | ||||
Approval Date: | Dec 4, 2015 | TE: | AA | RLD: | No |
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