Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214023
Company: NOVAST LABS

Products on ANDA 214023

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	0.9MG	TABLET;ORAL	Prescription	AB	No	No
CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	1.25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214023

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214023Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214023

CONJUGATED ESTROGENS

TABLET;ORAL; 0.9MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	0.9MG	TABLET;ORAL	Prescription	No	AB	214023	NOVAST LABS
PREMARIN	ESTROGENS, CONJUGATED	0.9MG	TABLET;ORAL	Prescription	Yes	AB	004782	WYETH PHARMS

TABLET;ORAL; 1.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	1.25MG	TABLET;ORAL	Prescription	No	AB	214023	NOVAST LABS
PREMARIN	ESTROGENS, CONJUGATED	1.25MG	TABLET;ORAL	Prescription	Yes	AB	004782	WYETH PHARMS