Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017364
Company: MEDPOINTE PHARM HLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AQUATENSEN METHYCLOTHIAZIDE 5MG 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
09/07/1977 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/1992 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1992 SUPPL-10 Labeling

Label is not available on this site.

12/03/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1988 SUPPL-8 Labeling

Label is not available on this site.

01/24/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1983 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/29/1987 SUPPL-4 Labeling

Label is not available on this site.

10/15/1981 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/26/1979 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/16/1980 SUPPL-1 Labeling

Label is not available on this site.

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