Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070703
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLDOPA METHYLDOPA 250MG 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
06/06/1986 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
05/12/1999 SUPPL-24 Labeling

Label is not available on this site.

06/11/1998 SUPPL-22 Labeling

Label is not available on this site.

09/27/1996 SUPPL-21 Labeling

Label is not available on this site.

08/25/1993 SUPPL-20 Labeling

Label is not available on this site.

06/22/1993 SUPPL-19 Labeling

Label is not available on this site.

11/16/1993 SUPPL-18 Labeling

Label is not available on this site.

11/16/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/16/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/03/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/04/1991 SUPPL-14 Labeling

Label is not available on this site.

01/28/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/01/1989 SUPPL-10 Labeling

Label is not available on this site.

11/22/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/10/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-4 Labeling

Label is not available on this site.

06/13/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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