Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040084
Company: MALLINCKRODT
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 750MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | TABLET;ORAL | Discontinued | None | No | No |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 660MG;10MG | TABLET;ORAL | Discontinued | None | No | No |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 650MG;10MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/01/1995 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/040084.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2011 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 12/24/2004 | SUPPL-28 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf | |
| 12/16/2004 | SUPPL-26 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf | |
| 12/16/2004 | SUPPL-25 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf | |
| 06/01/2004 | SUPPL-24 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf | |
| 11/13/2003 | SUPPL-23 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf | |
| 07/16/2003 | SUPPL-22 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf | |
| 04/25/2003 | SUPPL-21 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf | |
| 04/10/2003 | SUPPL-20 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf | |
| 09/27/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 12/02/2002 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 12/02/2002 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 04/11/2002 | SUPPL-16 | Manufacturing (CMC)-Facility |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 03/13/2000 | SUPPL-15 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 03/13/2000 | SUPPL-14 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 03/13/2000 | SUPPL-13 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 03/13/2000 | SUPPL-12 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 03/13/2000 | SUPPL-11 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 03/13/2000 | SUPPL-10 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 07/11/1997 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 10/16/1996 | SUPPL-8 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 10/16/1996 | SUPPL-7 | Manufacturing (CMC)-New Strength |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 07/03/1996 | SUPPL-6 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 07/03/1996 | SUPPL-5 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 07/03/1996 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 07/03/1996 | SUPPL-3 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 07/29/1996 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |
| 07/29/1996 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf |