Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011011
Company: AUXILIUM PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROBAXIN METHOCARBAMOL 500MG TABLET;ORAL Prescription AA Yes Yes
ROBAXIN-750 METHOCARBAMOL 750MG TABLET;ORAL Prescription AA 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
07/16/1957 ORIG-1 Approval Type 1 - New Molecular Entity 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
03/09/2015 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

05/01/2003 SUPPL-71 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011s070s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11011slr070,slr071ltr.pdf
05/01/2003 SUPPL-70 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011s070s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11011slr070,slr071ltr.pdf
04/22/1998 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

08/21/1990 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

01/06/1989 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

01/28/1987 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1986 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1986 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1985 SUPPL-60 Labeling

Label is not available on this site.

04/29/1985 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

04/29/1985 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

06/27/1984 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1983 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1983 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1982 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1982 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1982 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1982 SUPPL-49 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/21/1981 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

12/24/1981 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/1981 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1982 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1981 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1982 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1981 SUPPL-41 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/22/1981 SUPPL-40 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/07/1981 SUPPL-39 Labeling

Label is not available on this site.

10/28/1981 SUPPL-38 Labeling

Label is not available on this site.

02/11/1980 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/24/1979 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/21/1979 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/21/1979 SUPPL-20 Labeling

Label is not available on this site.

05/21/1979 SUPPL-19 Labeling

Label is not available on this site.

03/10/1976 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1975 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1974 SUPPL-15 Labeling

Label is not available on this site.

04/29/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1975 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1974 SUPPL-11 Labeling

Label is not available on this site.

10/17/1974 SUPPL-8 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
05/01/2003 SUPPL-71 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011s070s071lbl.pdf
05/01/2003 SUPPL-70 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011s070s071lbl.pdf

ROBAXIN

TABLET;ORAL; 500MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 200958 AUSTARPHARMA LLC
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 208507 BEXIMCO PHARMS USA
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 203550 DBL PHARMS
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 209312 GRANULES INDIA LTD
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 090200 HETERO LABS LTD III
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 085159 HIKMA INTL PHARMS
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 040489 OXFORD PHARMS
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 086989 PRINSTON INC
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 084277 WATSON LABS
ROBAXIN METHOCARBAMOL 500MG TABLET;ORAL Prescription Yes AA 011011 AUXILIUM PHARMS LLC

ROBAXIN-750

TABLET;ORAL; 750MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 200958 AUSTARPHARMA LLC
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 208507 BEXIMCO PHARMS USA
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 203550 DBL PHARMS
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 209312 GRANULES INDIA LTD
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 090200 HETERO LABS LTD III
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 085123 HIKMA INTL PHARMS
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 040489 OXFORD PHARMS
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 086988 PRINSTON INC
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 084276 WATSON LABS
ROBAXIN-750 METHOCARBAMOL 750MG TABLET;ORAL Prescription Yes AA 011011 AUXILIUM PHARMS LLC

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