Details for New Drug Application (NDA): 203484
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NDA 203484 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Dr Reddys Labs Sa, Granules, Alvogen, Halsey, Larken Labs Inc, Lgm Pharma, Mikart, Ne Rx Pharma, Quagen, Senores Pharms, and Watson Labs, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the BUTALBITAL AND ACETAMINOPHEN profile page.
The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven 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: | AA | 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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