Application 214025

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	TABLET;ORAL	0.3MG	No	No
002	CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	TABLET;ORAL	0.45MG	No	No
003	CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	TABLET;ORAL	0.625MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214025-001	CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	0.3MG	TABLET / ORAL	AB	2025-10-15
A214025-002	CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	0.45MG	TABLET / ORAL	AB	2025-10-15
A214025-003	CONJUGATED ESTROGENS	ESTROGENS, CONJUGATED	0.625MG	TABLET / ORAL	AB	2025-10-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214025-001	AB
A214025-002	AB
A214025-003	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A214025-001	CGT	2026-04-15
A214025-002	CGT	2026-04-15
A214025-003	CGT	2026-04-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214025-001	CONJUGATED ESTROGENS	0.3MG	TABLET / ORAL	AB	2025-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214025-002	CONJUGATED ESTROGENS	0.45MG	TABLET / ORAL	AB	2025-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214025-003	CONJUGATED ESTROGENS	0.625MG	TABLET / ORAL	AB	2025-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-001	CONJUGATED ESTROGENS	0.3MG	TABLET / ORAL	AB	2025-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-002	CONJUGATED ESTROGENS	0.45MG	TABLET / ORAL	AB	2025-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-003	CONJUGATED ESTROGENS	0.625MG	TABLET / ORAL	AB	2025-10-15	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-001	CONJUGATED ESTROGENS	0.3MG	TABLET / ORAL	AB	2025-10-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-002	CONJUGATED ESTROGENS	0.45MG	TABLET / ORAL	AB	2025-10-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-003	CONJUGATED ESTROGENS	0.625MG	TABLET / ORAL	AB	2025-10-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214025-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214025-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214025-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-003	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214025-001	CGT	2026-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214025-002	CGT	2026-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214025-003	CGT	2026-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-001	CGT	2026-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-002	CGT	2026-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214025-003	CGT	2026-04-15	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-001	CGT	2026-04-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-002	CGT	2026-04-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214025-003	CGT	2026-04-15	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
estrogens, conjugated	ESTROGENS, CONJUGATED	Ingenus Pharmaceuticals, LLC	b17eca23-f387-4243-a76a-bcf6b88aeef9	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214025 application number: ANDA214025

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84984	ORIG	2026-02-11
84983	ORIG	2026-02-11