Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013174
Company: CONCORDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYRENIUM TRIAMTERENE 50MG CAPSULE;ORAL Prescription AB Yes No
DYRENIUM TRIAMTERENE 100MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/10/1964 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2002 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

09/13/1994 SUPPL-58 Labeling

Label is not available on this site.

12/09/1992 SUPPL-57 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/03/1992 SUPPL-56 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/07/1990 SUPPL-54 Labeling

Label is not available on this site.

11/09/1988 SUPPL-53 Labeling

Label is not available on this site.

02/02/1988 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1987 SUPPL-51 Labeling

Label is not available on this site.

09/23/1987 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1982 SUPPL-46 Labeling

Label is not available on this site.

10/04/1985 SUPPL-45 Labeling

Label is not available on this site.

07/14/1980 SUPPL-44 Labeling

Label is not available on this site.

11/26/1979 SUPPL-43 Labeling

Label is not available on this site.

11/12/1979 SUPPL-41 Labeling

Label is not available on this site.

02/05/1981 SUPPL-40 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/07/1979 SUPPL-39 Labeling

Label is not available on this site.

11/16/1978 SUPPL-37 Labeling

Label is not available on this site.

08/15/1978 SUPPL-36 Labeling

Label is not available on this site.

12/12/1977 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1978 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1978 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1978 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/17/1978 SUPPL-31 Labeling

Label is not available on this site.

05/22/1978 SUPPL-30 Labeling

Label is not available on this site.

05/22/1978 SUPPL-29 Labeling

Label is not available on this site.

02/14/1977 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/1977 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/01/1977 SUPPL-26 Labeling

Label is not available on this site.

11/05/1976 SUPPL-24 Labeling

Label is not available on this site.

09/03/1976 SUPPL-23 Labeling

Label is not available on this site.

09/03/1976 SUPPL-22 Labeling

Label is not available on this site.

01/14/1976 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/03/1976 SUPPL-20 Labeling

Label is not available on this site.

01/14/1976 SUPPL-19 Labeling

Label is not available on this site.

06/02/1975 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1975 SUPPL-17 Labeling

Label is not available on this site.

01/14/1976 SUPPL-16 Unspecified

Label is not available on this site.

07/24/1975 SUPPL-14 Unspecified

Label is not available on this site.

06/02/1975 SUPPL-11 Unspecified

Label is not available on this site.

DYRENIUM

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYRENIUM TRIAMTERENE 50MG CAPSULE;ORAL Prescription Yes AB 013174 CONCORDIA
TRIAMTERENE TRIAMTERENE 50MG CAPSULE;ORAL Prescription No AB 211581 AGNITIO

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYRENIUM TRIAMTERENE 100MG CAPSULE;ORAL Prescription Yes AB 013174 CONCORDIA
TRIAMTERENE TRIAMTERENE 100MG CAPSULE;ORAL Prescription No AB 211581 AGNITIO

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