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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 214219

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NDA 214219 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 214219

Tradename:	TRIAZOLAM
Applicant:	Novast Labs
Ingredient:	triazolam
Patents:	0

Pharmacology for NDA: 214219

Medical Subject Heading (MeSH) Categories for 214219

Adjuvants, Anesthesia
Anti-Anxiety Agents
GABA Modulators

Suppliers and Packaging for NDA: 214219

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAZOLAM	triazolam	TABLET;ORAL	214219	ANDA	A-S Medication Solutions	50090-6471	50090-6471-0	30 TABLET in 1 BOTTLE (50090-6471-0)
TRIAZOLAM	triazolam	TABLET;ORAL	214219	ANDA	A-S Medication Solutions	50090-6471	50090-6471-1	100 TABLET in 1 BOTTLE (50090-6471-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.125MG
Approval Date:	Oct 20, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Oct 20, 2020	TE:	AB	RLD:	No

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