Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074699
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE | ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE | 650MG;EQ 25MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 03/24/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74699ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/18/2013 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/10/2011 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |