Drugs@FDA: FDA-Approved Drugs
Company:
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/31/1949 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2018 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/13/2017 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/06/2013 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/12/2009 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/30/2002 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/2003 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1995 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/11/1992 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1991 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1993 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/13/1990 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1989 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/18/1987 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1987 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 05/14/1982 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1986 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/14/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/15/1981 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/15/1981 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/08/1980 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1980 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/22/1978 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1976 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1976 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/29/1975 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/24/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006002s045lbl.pdf | |
| 07/13/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006002s044lbl.pdf | |
| 11/06/2013 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006002s043lbl.pdf | |
| 06/13/2003 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06002slr039_aralen_lbl.pdf |