Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011790
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 AUROBINDO PHARMA LTD
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 204404 MYLAN INSTITUTIONAL
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
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

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