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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084912
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG 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
12/17/1976 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-71 Labeling-Package Insert

Label is not available on this site.

08/06/2020 SUPPL-70 Labeling-Package Insert

Label is not available on this site.

12/01/1998 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

01/12/1998 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

07/27/1995 SUPPL-66 Labeling

Label is not available on this site.

01/24/1994 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

03/30/1994 SUPPL-64 Labeling

Label is not available on this site.

08/11/1992 SUPPL-63 Labeling

Label is not available on this site.

11/09/1989 SUPPL-62 Labeling

Label is not available on this site.

11/21/1989 SUPPL-61 Labeling

Label is not available on this site.

08/23/1989 SUPPL-60 Labeling

Label is not available on this site.

05/27/1988 SUPPL-59 Labeling

Label is not available on this site.

08/21/1990 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

08/21/1990 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

06/03/1987 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

06/03/1987 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/03/1987 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

06/03/1987 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/12/1985 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

04/23/1985 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/17/1983 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

08/17/1983 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

08/09/1982 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

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