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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214219
Company: NOVAST LABS

Products on ANDA 214219

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAZOLAM	TRIAZOLAM	0.125MG	TABLET;ORAL	Prescription	AB	No	No
TRIAZOLAM	TRIAZOLAM	0.25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/2020	ORIG-1	Approval		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
11/28/2023	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
07/26/2022	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/26/2022	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/26/2022	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214219

TRIAZOLAM

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALCION	TRIAZOLAM	0.125MG	TABLET;ORAL	Prescription	Yes	AB	017892	PFIZER
TRIAZOLAM	TRIAZOLAM	0.125MG	TABLET;ORAL	Prescription	No	AB	214219	NOVAST LABS
TRIAZOLAM	TRIAZOLAM	0.125MG	TABLET;ORAL	Prescription	No	AB	216890	SANDOZ
TRIAZOLAM	TRIAZOLAM	0.125MG	TABLET;ORAL	Prescription	No	AB	213003	ZYDUS PHARMS

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALCION	TRIAZOLAM	0.25MG	TABLET;ORAL	Prescription	Yes	AB	017892	PFIZER
TRIAZOLAM	TRIAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	214219	NOVAST LABS
TRIAZOLAM	TRIAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	216890	SANDOZ
TRIAZOLAM	TRIAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	213003	ZYDUS PHARMS

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