Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070265
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA 25MG;250MG TABLET;ORAL Prescription None No Yes
METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA 15MG;250MG TABLET;ORAL Prescription 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
01/23/1986 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
08/20/2020 SUPPL-47 Labeling-Package Insert

Label is not available on this site.

12/12/2005 SUPPL-28 Labeling

Label is not available on this site.

09/05/2001 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-23 Labeling

Label is not available on this site.

01/24/2000 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/16/1998 SUPPL-21 Labeling

Label is not available on this site.

02/25/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/27/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/20/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/20/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/20/1996 SUPPL-16 Labeling

Label is not available on this site.

06/20/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/20/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/29/1993 SUPPL-11 Labeling

Label is not available on this site.

09/26/1991 SUPPL-10 Labeling

Label is not available on this site.

06/20/1991 SUPPL-9 Labeling

Label is not available on this site.

01/31/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/20/1989 SUPPL-7 Labeling

Label is not available on this site.

01/25/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/25/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/07/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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