Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012281
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 No 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.

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