Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VICODIN ES | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 750MG;7.5MG | 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 |
---|---|---|---|---|---|---|---|
12/09/1988 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089736.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/26/2006 | SUPPL-13 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/089736s013lbl.pdf | |
04/02/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/27/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/16/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/25/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/28/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
07/17/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
07/17/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/17/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/17/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/17/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/17/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/17/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/26/2006 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/089736s013lbl.pdf |