Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019129
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAXZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription AB Yes Yes
MAXZIDE-25 HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription AB Yes 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
10/22/1984 ORIG-1 Approval Type 3 - New Dosage Form 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
05/11/2015 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/20/2011 SUPPL-43 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019129s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019129s043ltr.pdf
02/02/2001 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1999 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/10/1997 SUPPL-28 Labeling

Label is not available on this site.

09/12/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/01/1992 SUPPL-26 Labeling

Label is not available on this site.

06/06/1991 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/06/1989 SUPPL-24 Labeling

Label is not available on this site.

07/21/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1988 SUPPL-22 Labeling

Label is not available on this site.

05/13/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/25/1988 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/13/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/04/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/29/1987 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/09/1990 SUPPL-14 Labeling

Label is not available on this site.

04/14/1987 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/08/1986 SUPPL-11 Labeling

Label is not available on this site.

01/27/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1988 SUPPL-8 Efficacy-New Dosing Regimen

Label is not available on this site.

10/08/1985 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/16/1985 SUPPL-6 Labeling

Label is not available on this site.

05/10/1985 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1985 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/01/1985 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/03/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/20/2011 SUPPL-43 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019129s043lbl.pdf

MAXZIDE

TABLET;ORAL; 50MG;75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAXZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription Yes AB 019129 MYLAN PHARMS INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 071251 APOTEX INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 072011 SANDOZ
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 071851 WATSON LABS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 208360 ZYDUS PHARMS

MAXZIDE-25

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAXZIDE-25 HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription Yes AB 019129 MYLAN PHARMS INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 071251 APOTEX INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 073281 SANDOZ
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 073449 WATSON LABS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 208360 ZYDUS PHARMS

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