Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070076
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLDOPA METHYLDOPA 500MG TABLET;ORAL Prescription AB No Yes
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
10/26/2004 SUPPL-34 Labeling

Label is not available on this site.

08/06/2004 SUPPL-31 Labeling

Label is not available on this site.

06/25/1999 SUPPL-29 Labeling

Label is not available on this site.

08/25/1998 SUPPL-26 Labeling

Label is not available on this site.

05/20/1996 SUPPL-22 Labeling

Label is not available on this site.

03/19/1993 SUPPL-19 Labeling

Label is not available on this site.

07/16/1992 SUPPL-15 Labeling

Label is not available on this site.

12/17/1990 SUPPL-13 Labeling

Label is not available on this site.

04/11/1989 SUPPL-6 Labeling

Label is not available on this site.

METHYLDOPA

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLDOPA METHYLDOPA 500MG TABLET;ORAL Prescription No AB 070085 ACCORD HLTHCARE
METHYLDOPA METHYLDOPA 500MG TABLET;ORAL Prescription No AB 070076 MYLAN

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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