Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070075
Company: MYLAN
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
04/18/1985 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
08/04/2004 SUPPL-32 Labeling

Label is not available on this site.

06/25/1999 SUPPL-30 Labeling

Label is not available on this site.

01/19/2000 SUPPL-29 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/22/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/25/1998 SUPPL-27 Labeling

Label is not available on this site.

07/30/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/20/1996 SUPPL-23 Labeling

Label is not available on this site.

10/29/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/19/1993 SUPPL-20 Labeling

Label is not available on this site.

07/16/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/16/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/16/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/16/1992 SUPPL-16 Labeling

Label is not available on this site.

07/16/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/17/1990 SUPPL-14 Labeling

Label is not available on this site.

01/31/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/05/1989 SUPPL-11 Labeling

Label is not available on this site.

07/01/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/01/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/09/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/22/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/17/1986 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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