Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016042
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;50MG CAPSULE;ORAL Discontinued None No No
DYAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG 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
12/02/1965 ORIG-1 Approval Type 4 - New Combination 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
03/15/2011 SUPPL-78 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016042s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016042s078ltr.pdf
02/23/2010 SUPPL-77 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016042s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016042s077ltr.pdf
05/18/2007 SUPPL-74 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016042s074ltr.pdf
12/20/2000 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

02/23/2001 SUPPL-69 Labeling

Label is not available on this site.

03/16/1999 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

08/31/1998 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

12/01/1994 SUPPL-66 Labeling

Label is not available on this site.

05/20/1994 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1994 SUPPL-64 Labeling

Label is not available on this site.

05/01/1992 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1991 SUPPL-61 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/23/1988 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1986 SUPPL-57 Labeling

Label is not available on this site.

03/07/1985 SUPPL-56 Labeling

Label is not available on this site.

03/03/1994 SUPPL-55 Efficacy-New Indication

Label is not available on this site.

05/13/1983 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

01/03/1985 SUPPL-52 Labeling

Label is not available on this site.

10/08/1982 SUPPL-51 Labeling

Label is not available on this site.

08/25/1982 SUPPL-49 Labeling

Label is not available on this site.

10/30/1981 SUPPL-48 Labeling

Label is not available on this site.

04/26/1988 SUPPL-47 Labeling

Label is not available on this site.

02/23/1982 SUPPL-46 Labeling

Label is not available on this site.

07/14/1980 SUPPL-45 Labeling

Label is not available on this site.

01/27/1981 SUPPL-44 Labeling

Label is not available on this site.

01/14/1980 SUPPL-43 Labeling

Label is not available on this site.

12/06/1979 SUPPL-41 Labeling

Label is not available on this site.

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

Label is not available on this site.

09/18/1979 SUPPL-39 Labeling

Label is not available on this site.

09/18/1979 SUPPL-38 Labeling

Label is not available on this site.

09/18/1979 SUPPL-37 Labeling

Label is not available on this site.

01/19/1978 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1978 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

Label is not available on this site.

02/22/1978 SUPPL-33 Labeling

Label is not available on this site.

02/22/1978 SUPPL-32 Labeling

Label is not available on this site.

02/22/1978 SUPPL-31 Labeling

Label is not available on this site.

02/22/1978 SUPPL-30 Labeling

Label is not available on this site.

06/14/1977 SUPPL-29 Manufacturing (CMC)-Formulation

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.

04/12/1977 SUPPL-26 Labeling

Label is not available on this site.

11/03/1976 SUPPL-25 Labeling

Label is not available on this site.

05/21/1976 SUPPL-24 Labeling

Label is not available on this site.

05/21/1976 SUPPL-23 Labeling

Label is not available on this site.

01/27/1976 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/12/1975 SUPPL-19 Labeling

Label is not available on this site.

06/23/1976 SUPPL-18 Labeling

Label is not available on this site.

02/27/1975 SUPPL-17 Labeling

Label is not available on this site.

02/27/1975 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/27/1976 SUPPL-14 Unspecified

Label is not available on this site.

06/23/1976 SUPPL-8 Unspecified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/15/2011 SUPPL-78 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016042s078lbl.pdf
02/23/2010 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016042s077lbl.pdf

DYAZIDE

CAPSULE;ORAL; 25MG;37.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription Yes AB 016042 GLAXOSMITHKLINE LLC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 075052 DURAMED PHARMS BARR
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 201407 LANNETT CO INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 074701 MYLAN
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 074821 SANDOZ
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 208358 ZYDUS PHARMS

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