Application 213046
- Type
- ANDA
- Sponsor
- TARO PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | CAPSULE;ORAL | 300MG;50MG;40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-170 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | NORTHSTAR RX LLC | ANDA | Current |
| 51672-4222 | Butalbital, Acetaminophen and Caffeine | butalbital, acetaminophen, and caffeine | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4222 | Butalbital, Acetaminophen and Caffeine | butalbital, acetaminophen, and caffeine | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |