Application 020232
- Type
- NDA
- Sponsor
- ACTAVIS LABS UT INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FIORICET W/ CODEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | CAPSULE;ORAL | 325MG;50MG;40MG;30MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-3220 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0591-3220 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0591-3220 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0591-3220 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0591-3220 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 63629-3152 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-3152 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-3152 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |