Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070074
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLDOPA METHYLDOPA 500MG 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
10/09/1986 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
08/05/1998 SUPPL-23 Labeling

Label is not available on this site.

12/01/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/11/1996 SUPPL-21 Labeling

Label is not available on this site.

12/23/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/21/1993 SUPPL-18 Labeling

Label is not available on this site.

04/03/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/06/1991 SUPPL-13 Labeling

Label is not available on this site.

04/23/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/25/1989 SUPPL-10 Labeling

Label is not available on this site.

01/25/1989 SUPPL-9 Labeling

Label is not available on this site.

01/11/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/31/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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