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Details for New Drug Application (NDA): 019129

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NDA 019129 describes MAXZIDE-25, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from eight suppliers. Additional details are available on the MAXZIDE-25 profile page.

The generic ingredient in MAXZIDE-25 is hydrochlorothiazide; triamterene. There are thirty-one drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.

Summary for NDA: 019129

Tradename:
MAXZIDE
Applicant:
Mylan Pharms Inc
Ingredient:
hydrochlorothiazide; triamterene
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 019129

Suppliers and Packaging for NDA: 019129

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXZIDE
hydrochlorothiazide; triamterene
TABLET;ORAL 019129 NDA Mylan Pharmaceuticals Inc. 0378-0460 0378-0460-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0460-01)
MAXZIDE
hydrochlorothiazide; triamterene
TABLET;ORAL 019129 NDA Mylan Pharmaceuticals Inc. 0378-0464 0378-0464-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0464-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;75MG
Approval Date:Oct 22, 1984TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;37.5MG
Approval Date:May 13, 1988TE:ABRLD:No

Expired Orange Book Patents for NDA: 019129

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms Inc
MAXZIDE
hydrochlorothiazide; triamterene
TABLET;ORAL019129-001Oct 22, 19844,105,783► subscribe
Mylan Pharms Inc
MAXZIDE-25
hydrochlorothiazide; triamterene
TABLET;ORAL019129-003May 13, 19884,444,769► subscribe
Mylan Pharms Inc
MAXZIDE
hydrochlorothiazide; triamterene
TABLET;ORAL019129-001Oct 22, 19844,444,769► subscribe
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