Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070070
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLDOPA METHYLDOPA 125MG 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
10/15/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2011 SUPPL-24 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/10/1999 SUPPL-23 Labeling

Label is not available on this site.

06/11/1998 SUPPL-22 Labeling

Label is not available on this site.

02/18/1997 SUPPL-21 Labeling

Label is not available on this site.

04/30/1993 SUPPL-20 Labeling

Label is not available on this site.

03/20/1991 SUPPL-19 Labeling

Label is not available on this site.

03/27/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/27/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/27/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/12/1990 SUPPL-15 Labeling

Label is not available on this site.

03/28/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/02/1988 SUPPL-11 Labeling

Label is not available on this site.

09/07/1988 SUPPL-10 Labeling

Label is not available on this site.

10/13/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/13/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/09/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/09/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/09/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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