Acetaminophen / butalbital Oral Capsule
- Brand(s)
- Phrenilin
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Oldest Current Product
- 2004-05-03
- License(s)
- ANDA
- RxNORM
- ORAL CAPSULE\ACETAMINOPHEN:BUTALBITAL
- FDAOB
- ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL
- SPL Active
- ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL
- SPL Moiety
- ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL
product(s) by strength(s)
invalid application product(s)
| # | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 001870844 | Phrenilin | ANDA | Valeant Pharmaceuticals North America Llc | 2004-05-03 | 2016-09-30 | ACETAMINOPHEN, BUTALBITAL | ORAL | CAPSULE | ANDA088831 | a81c62d2-8151-42db-bda7-e08578ac5089 |
| # | id | title | deprecated | applicant | approved | approved drug |
|---|
| 1 | ANDA088831 | PHRENILIN FORTE | True | VALEANT PHARMACEUTICALS INTERNATIONAL | 1985-06-19 | ANDA088831_001 |
| 2 | ANDA088889 | BANCAP | True | FOREST PHARMACEUTICALS INC | 1986-01-16 | ANDA088889_001 |
| 3 | ANDA088991 | BUCET | True | MALLINCKRODT CHEMICAL INC | 1985-06-28 | ANDA088991_001 |
| 4 | ANDA089268 | TRIAPRIN | True | DUNHALL PHARMACEUTICALS INC | 1987-07-02 | ANDA089268_001 |
| 5 | ANDA089405 | TENCON | True | MALLINCKRODT CHEMICAL INC | 1990-05-15 | ANDA089405_001 |
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|
| 1 | ANDA088831_001 | discontinued | ACETAMINOPHEN (650MG), BUTALBITAL (50MG) | ORAL | CAPSULE | False | 1985-06-19 | PHRENILIN FORTE |
| 2 | ANDA088889_001 | discontinued | ACETAMINOPHEN (325MG), BUTALBITAL (50MG) | ORAL | CAPSULE | False | 1986-01-16 | BANCAP |
| 3 | ANDA088991_001 | discontinued | ACETAMINOPHEN (650MG), BUTALBITAL (50MG) | ORAL | CAPSULE | False | 1985-06-28 | BUCET |
| 4 | ANDA089268_001 | discontinued | BUTALBITAL (50MG), ACETAMINOPHEN (325MG) | ORAL | CAPSULE | False | 1987-07-02 | TRIAPRIN |
| 5 | ANDA089405_001 | discontinued | BUTALBITAL (50MG), ACETAMINOPHEN (650MG) | ORAL | CAPSULE | False | 1990-05-15 | TENCON |
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|
| 1 | a81c62d2-8151-42db-bda7-e08578ac5089 (view SPL) | PHRENILIN (Butalbital 50 mg and Acetaminophen 325 mg Tablet) | prescription | Human Prescription | Valeant Pharmaceuticals North America Llc | MANUFACTURE | 2014-12-23 | 11 | 001870844, 001870842 | Acetaminophen / butalbital Oral Tablet |