Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROBAXIN | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/10/1959 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 08/12/2014 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2014 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/2004 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11790slr046_robaxin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11790slr046ltr.pdf | |
| 02/28/2001 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1999 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1998 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1990 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/02/1988 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1987 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/07/1987 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/03/1986 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1983 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 09/03/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1981 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1982 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/10/1981 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/03/1980 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/23/1980 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/23/1980 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1980 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1979 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1976 | SUPPL-12 | 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 |
|---|---|---|---|---|---|
| 05/04/2004 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11790slr046_robaxin_lbl.pdf |
ROBAXIN
SOLUTION;IM-IV; 1GM/10ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 207496 | AM REGENT |
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 206128 | EUGIA PHARMA |
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 209331 | FRESENIUS KABI USA |
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 211504 | GLAND PHARMA LTD |
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 205354 | MONTEREY PHARMS LLC |
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 206071 | NAVINTA LLC |
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 205404 | SAGENT PHARMS INC |
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 208116 | SLATE RUN PHARMA |
| METHOCARBAMOL | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | No | AP | 207522 | SOMERSET THERAPS LLC |
| ROBAXIN | METHOCARBAMOL | 1GM/10ML (100MG/ML) | SOLUTION;IM-IV | Prescription | Yes | AP | 011790 | HIKMA |