Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070084
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLDOPA METHYLDOPA 250MG TABLET;ORAL Prescription AB 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-30 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/10/1999 SUPPL-29 Labeling

Label is not available on this site.

07/12/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-27 Labeling

Label is not available on this site.

05/18/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-25 Labeling

Label is not available on this site.

08/31/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/31/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/30/1993 SUPPL-22 Labeling

Label is not available on this site.

03/17/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/10/1991 SUPPL-20 Labeling

Label is not available on this site.

01/15/1991 SUPPL-19 Labeling

Label is not available on this site.

12/12/1990 SUPPL-18 Labeling

Label is not available on this site.

10/25/1989 SUPPL-16 Bioequivalence

Label is not available on this site.

11/21/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/21/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/02/1988 SUPPL-12 Labeling

Label is not available on this site.

01/28/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-8 Labeling

Label is not available on this site.

10/13/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/13/1987 SUPPL-6 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-2 Manufacturing (CMC)

Label is not available on this site.

METHYLDOPA

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLDOPA METHYLDOPA 250MG TABLET;ORAL Prescription No AB 070084 ACCORD HLTHCARE
METHYLDOPA METHYLDOPA 250MG TABLET;ORAL Prescription No AB 070075 MYLAN
METHYLDOPA METHYLDOPA 250MG TABLET;ORAL Prescription No AB 070076 MYLAN

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