Drugs@FDA: FDA-Approved Drugs
Company: ROBINS AH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROBAXISAL | ASPIRIN; METHOCARBAMOL | 325MG;400MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/15/1960 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/10/2004 | SUPPL-52 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12281slr050,051,051ltr.pdf |
| 02/10/2004 | SUPPL-51 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12281slr050,051,051ltr.pdf |
| 02/10/2004 | SUPPL-50 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12281slr050,051,051ltr.pdf |
| 04/22/1998 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/1990 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1987 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1988 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1989 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 06/08/1984 | SUPPL-40 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1983 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1983 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/26/1982 | SUPPL-33 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/22/1981 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1981 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1981 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/26/1982 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1981 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1981 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/16/1981 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/19/1979 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/17/1979 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1980 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1980 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1979 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/11/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1975 | SUPPL-5 | Labeling |
Label is not available on this site. |