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CAPTOPRIL AND HYDROCHLOROTHIAZIDE از شرکت IVAX SUB TEVA PHARMS

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CAPTOPRIL AND HYDROCHLOROTHIAZIDE از شرکت IVAX SUB TEVA PHARMS

Abbreviated New Drug Application (ANDA): 075055

Company: IVAX SUB TEVA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;15MG TABLET;ORAL Discontinued

None

No No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;25MG TABLET;ORAL Discontinued

None

No No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;25MG TABLET;ORAL Discontinued

None

No No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;15MG 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
06/18/1998 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75055ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

11/07/2001 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/13/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

04/13/2001 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/13/2001 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

03/28/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

07/23/1999 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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