Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070343
Company: HERITAGE PHARMA
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
02/20/1986 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
08/17/2011 SUPPL-58 Labeling

Label is not available on this site.

07/26/2005 SUPPL-52 Labeling

Label is not available on this site.

07/29/2002 SUPPL-46 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-44 Manufacturing (CMC)-Facility

Label is not available on this site.

07/26/2000 SUPPL-43 Manufacturing (CMC)-Facility

Label is not available on this site.

03/22/2000 SUPPL-42 Labeling

Label is not available on this site.

03/22/2000 SUPPL-41 Manufacturing (CMC)-Facility

Label is not available on this site.

07/26/2000 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

07/26/2000 SUPPL-39 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/26/2000 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/2000 SUPPL-37 Labeling

Label is not available on this site.

03/28/2000 SUPPL-36 Manufacturing (CMC)-Facility

Label is not available on this site.

03/22/2000 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-34 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-33 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/28/1999 SUPPL-31 Labeling

Label is not available on this site.

07/20/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/10/1996 SUPPL-27 Labeling

Label is not available on this site.

01/06/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/06/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/13/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/01/1993 SUPPL-23 Labeling

Label is not available on this site.

08/12/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/12/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/12/1991 SUPPL-20 Labeling

Label is not available on this site.

09/27/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/27/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/29/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/29/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/09/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/20/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/12/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/12/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/12/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/29/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/29/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/20/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/10/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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