Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070614
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA 50MG;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
02/02/1987 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-27 Labeling-Package Insert

Label is not available on this site.

01/21/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/06/1996 SUPPL-25 Labeling

Label is not available on this site.

01/27/1994 SUPPL-24 Labeling

Label is not available on this site.

07/02/1993 SUPPL-23 Labeling

Label is not available on this site.

07/29/1992 SUPPL-22 Labeling

Label is not available on this site.

06/09/1992 SUPPL-21 Labeling

Label is not available on this site.

12/22/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/30/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/30/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/30/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/30/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/17/1989 SUPPL-14 Labeling

Label is not available on this site.

08/18/1988 SUPPL-13 Labeling

Label is not available on this site.

01/22/1988 SUPPL-12 Labeling

Label is not available on this site.

02/04/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/24/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/13/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/14/1987 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.

09/29/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-3 Labeling

Label is not available on this site.

08/06/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/28/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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