Acetaminophen / Oxycodone Oral Capsule
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Oldest Current Product
- 1995-07-03
- License(s)
- ANDA
- RxNORM
- ORAL CAPSULE\ACETAMINOPHEN:OXYCODONE
- FDAOB
- ORAL\CAPSULE\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
- SPL Active
- ORAL\CAPSULE, GELATIN COATED\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
ORAL\CAPSULE\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE - SPL Moiety
- ORAL\CAPSULE, GELATIN COATED\ACETAMINOPHEN: OXYCODONE
ORAL\CAPSULE\ACETAMINOPHEN: OXYCODONE
product(s) by strength(s)
invalid application product(s)
| # | id | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000542795 | ANDA | Roxane Laboratories, Inc | 1995-07-03 | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE | ORAL | CAPSULE | ANDA040061 | 61b0c7d6-21ff-4a07-b737-1edd105bb74d | |
| 2 | 004060532 | ANDA | Mallinckrodt, Inc. | 2009-07-07 | 2017-08-31 | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE | ORAL | CAPSULE, GELATIN COATED | ANDA040257 | 3bfe9f12-5af5-404e-9ba5-98ed8d7d644d |
| 3 | 005550658 | ANDA | Barr Laboratories Inc. | 1999-05-20 | 2016-02-29 | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE | ORAL | CAPSULE | ANDA040289 | 28e157c7-6b3b-4dc2-adf3-e6c212515118 |
| 4 | 005910737 | ANDA | Watson Laboratories, Inc. | 1997-10-30 | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE | ORAL | CAPSULE | ANDA040234 | a1df89be-8dbe-465b-9d52-a4e767ab7dc3 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA040061 | ROXILOX | True | ROXANE LABORATORIES INC | 1995-07-03 | ANDA040061_001 | Fluphenazine Oral Solution |
| 2 | ANDA040106 | OXYCODONE AND ACETAMINOPHEN | True | VINTAGE PHARMACEUTICALS INC | 1996-07-30 | ANDA040106_001 | Fluphenazine Oral Solution |
| 3 | ANDA040199 | OXYCODONE AND ACETAMINOPHEN | True | ACTAVIS ELIZABETH LLC | 1998-12-30 | ANDA040199_001 | Fluphenazine Oral Solution |
| 4 | ANDA040219 | OXYCODONE AND ACETAMINOPHEN | True | MUTUAL PHARMACEUTICAL CO INC | 1998-01-22 | ANDA040219_001 | Fluphenazine Oral Solution |
| 5 | ANDA040234 | OXYCODONE AND ACETAMINOPHEN | True | WATSON LABORATORIES INC | 1997-10-30 | ANDA040234_001 | Fluphenazine Oral Solution |
| 6 | ANDA040257 | OXYCODONE AND ACETAMINOPHEN | True | MALLINCKRODT CHEMICAL INC | 1998-08-04 | ANDA040257_001 | Fluphenazine Oral Solution |
| 7 | ANDA040289 | OXYCODONE AND ACETAMINOPHEN | True | DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC | 1999-03-16 | ANDA040289_001 | Fluphenazine Oral Solution |
| 8 | ANDA040303 | OXYCODONE AND ACETAMINOPHEN | True | VINTAGE PHARMACEUTICALS LLC | 1999-12-30 | ANDA040303_001 | Fluphenazine Oral Solution |
| 9 | ANDA040304 | OXYCODONE AND ACETAMINOPHEN | True | BARR LABORATORIES INC | 2000-10-02 | ANDA040304_001 | Fluphenazine Oral Solution |
| 10 | ANDA088246 | TYLOX-325 | True | ORTHO MCNEIL PHARMACEUTICAL INC | 1984-11-08 | ANDA088246_001 | Fluphenazine Oral Solution |
| 11 | ANDA088790 | TYLOX | True | JANSSEN PHARMACEUTICALS INC | 1984-12-12 | ANDA088790_001 | Fluphenazine Oral Solution |
| 12 | ANDA089994 | OXYCODONE AND ACETAMINOPHEN | True | HALSEY DRUG CO INC | 1989-05-04 | ANDA089994_001 | Fluphenazine Oral Solution |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040061_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG) | ORAL | CAPSULE | False | 1995-07-03 | ROXILOX |
| 2 | ANDA040106_001 | discontinued | ACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG) | ORAL | CAPSULE | False | 1996-07-30 | OXYCODONE AND ACETAMINOPHEN |
| 3 | ANDA040199_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG) | ORAL | CAPSULE | False | 1998-12-30 | OXYCODONE AND ACETAMINOPHEN |
| 4 | ANDA040219_001 | discontinued | ACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG) | ORAL | CAPSULE | False | 1998-01-22 | OXYCODONE AND ACETAMINOPHEN |
| 5 | ANDA040234_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG) | ORAL | CAPSULE | False | 1997-10-30 | OXYCODONE AND ACETAMINOPHEN |
| 6 | ANDA040257_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG) | ORAL | CAPSULE | False | 1998-08-04 | OXYCODONE AND ACETAMINOPHEN |
| 7 | ANDA040289_001 | discontinued | ACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG) | ORAL | CAPSULE | False | 1999-03-16 | OXYCODONE AND ACETAMINOPHEN |
| 8 | ANDA040303_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG) | ORAL | CAPSULE | False | 1999-12-30 | OXYCODONE AND ACETAMINOPHEN |
| 9 | ANDA040304_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG) | ORAL | CAPSULE | False | 2000-10-02 | OXYCODONE AND ACETAMINOPHEN |
| 10 | ANDA088246_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (325MG) | ORAL | CAPSULE | False | 1984-11-08 | TYLOX-325 |
| 11 | ANDA088790_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG) | ORAL | CAPSULE | False | 1984-12-12 | TYLOX |
| 12 | ANDA089994_001 | discontinued | OXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG) | ORAL | CAPSULE | False | 1989-05-04 | OXYCODONE AND ACETAMINOPHEN |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 28e157c7-6b3b-4dc2-adf3-e6c212515118 (view SPL) | OXYCODONE AND ACETAMINOPHEN CAPSULES USP CII | prescription | Human Prescription | Barr Laboratories Inc. | 2014-07-08 | 6 | 005550658 | |
| 2 | 3bfe9f12-5af5-404e-9ba5-98ed8d7d644d (view SPL) | OXYCODONE AND ACETAMINOPHENCAPSULES USP5 mg/500 mg CII Rx only Analgesic For Oral Use | prescription | Human Prescription | Mallinckrodt, Inc. | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2015-06-26 | 11 | 004060532 |
| 3 | 61b0c7d6-21ff-4a07-b737-1edd105bb74d (view SPL) | OXYCODONE and ACETAMINOPHEN Capsules USP CII | prescription | Human Prescription | Roxane Laboratories, Inc | API MANUFACTURE, MANUFACTURE | 2013-08-05 | 9 | 000542795 |
| 4 | a1df89be-8dbe-465b-9d52-a4e767ab7dc3 (view SPL) | Oxycodone and Acetaminophen Capsules USPCII Revised: August 2013 Rx only 173228-2 | prescription | Human Prescription | Watson Laboratories, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2013-08-13 | 6 | 005910737 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII