Details for New Drug Application (NDA): 020232
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NDA 020232 describes FIORICET W/ CODEINE, which is a drug marketed by Actavis Labs Ut Inc and is included in one NDA. It is available from one supplier. Additional details are available on the FIORICET W/ CODEINE profile page.
The generic ingredient in FIORICET W/ CODEINE is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.
The generic ingredient in FIORICET W/ CODEINE is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.
Summary for 020232
| Tradename: | FIORICET W/ CODEINE |
| Applicant: | Actavis Labs Ut Inc |
| Ingredient: | acetaminophen; butalbital; caffeine; codeine phosphate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020232
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FIORICET W/ CODEINE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 020232 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0591-3220 | 0591-3220-01 | 100 CAPSULE in 1 BOTTLE (0591-3220-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG;30MG | ||||
| Approval Date: | Jul 30, 1992 | TE: | AB | RLD: | Yes | ||||
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