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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213003

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NDA 213003 describes TRIAZOLAM, which is a drug marketed by Hikma, Norvium Bioscience, Novast Labs, Sandoz, Watson Labs, and Zydus Pharms, and is included in six NDAs. It is available from six suppliers. Additional details are available on the TRIAZOLAM profile page.

The generic ingredient in TRIAZOLAM is triazolam. There are six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the triazolam profile page.

Summary for 213003

Tradename:	TRIAZOLAM
Applicant:	Zydus Pharms
Ingredient:	triazolam
Patents:	0

Pharmacology for NDA: 213003

Medical Subject Heading (MeSH) Categories for 213003

Adjuvants, Anesthesia
Anti-Anxiety Agents
GABA Modulators

Suppliers and Packaging for NDA: 213003

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAZOLAM	triazolam	TABLET;ORAL	213003	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1289	70710-1289-1	100 TABLET in 1 BOTTLE (70710-1289-1)
TRIAZOLAM	triazolam	TABLET;ORAL	213003	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1289	70710-1289-5	500 TABLET in 1 BOTTLE (70710-1289-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.125MG
Approval Date:	Dec 28, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Dec 28, 2022	TE:	AB	RLD:	No

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