Acetaminophen / Caffeine / dihydrocodeine Oral Tablet
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Oldest Current Product
- 2008-05-20
- License(s)
- ANDA
- RxNORM
- ORAL TABLET\ACETAMINOPHEN:CAFFEINE:DIHYDROCODEINE
- FDAOB
- ORAL\TABLET\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE BITARTRATE
- SPL Active
- ORAL\TABLET\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE BITARTRATE
- SPL Moiety
- ORAL\TABLET\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE
product(s) by strength(s)
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685900 | ANDA | Physicians Total Care, Inc. | 2008-05-20 | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE | ORAL | TABLET | 643760611 | ANDA040701 | f3ddb645-028a-4c54-96b9-dbfecacf19bb |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA040316 | ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | True | MIKART INC | 1999-04-28 | ANDA040316_001 |
| 2 | ANDA040637 | ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | True | WEST-WARD PHARMACEUTICAL CORP | 2006-09-22 | ANDA040637_001 |
| 3 | ANDA040701 | ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | True | BOCA PHARMACAL LLC | 2007-04-03 | ANDA040701_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040316_001 | discontinued | CAFFEINE (60MG), DIHYDROCODEINE BITARTRATE (32MG), ACETAMINOPHEN (712.8MG) | ORAL | TABLET | False | 1999-04-28 | ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE |
| 2 | ANDA040637_001 | discontinued | CAFFEINE (60MG), DIHYDROCODEINE BITARTRATE (32MG), ACETAMINOPHEN (712.8MG) | ORAL | TABLET | False | 2006-09-22 | ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE |
| 3 | ANDA040701_001 | discontinued | CAFFEINE (60MG), DIHYDROCODEINE BITARTRATE (32MG), ACETAMINOPHEN (712.8MG) | ORAL | TABLET | False | 2007-04-03 | ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | f3ddb645-028a-4c54-96b9-dbfecacf19bb (view SPL) | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2009-11-24 | 2 | 548685900 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII