Application 021633

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEMTRACE	ESTRADIOL ACETATE	TABLET;ORAL	0.45MG	Yes	No
002	FEMTRACE	ESTRADIOL ACETATE	TABLET;ORAL	0.9MG	Yes	No
003	FEMTRACE	ESTRADIOL ACETATE	TABLET;ORAL	1.8MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N021633-001	FEMTRACE	ESTRADIOL ACETATE	0.45MG	TABLET / ORAL	RLD	2004-08-20
N021633-002	FEMTRACE	ESTRADIOL ACETATE	0.9MG	TABLET / ORAL	RLD	2004-08-20
N021633-003	FEMTRACE	ESTRADIOL ACETATE	1.8MG	TABLET / ORAL	RLD	2004-08-20

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.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021633-002	FEMTRACE	0.9MG	TABLET / ORAL	RLD	2004-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021633-003	FEMTRACE	1.8MG	TABLET / ORAL	RLD	2004-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021633-001	FEMTRACE	0.45MG	TABLET / ORAL	RLD	2004-08-20	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 2 of 5 · 171 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021633-002	7572779	2025-10-02	U-904			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021633-003	7572779	2025-10-02	U-904			`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021633-001	7572779	2025-10-02	U-904			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021633-002	7572779	2025-10-02	U-904			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021633-003	7572779	2025-10-02	U-904			`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021633-001	7572779	2025-10-02	U-904			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021633-002	7572779	2025-10-02	U-904			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021633-003	7572779	2025-10-02	U-904			`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021633-001	6962908	2021-12-21		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021633-001	7799771	2021-12-21		Drug product	2010-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021633-001	7572779	2025-10-02	U-904			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021633-002	6962908	2021-12-21		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021633-002	7799771	2021-12-21		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021633-002	7572779	2025-10-02	U-904			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021633-003	6962908	2021-12-21		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021633-003	7799771	2021-12-21		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021633-003	7572779	2025-10-02	U-904			`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021633-001	7572779	2025-10-02	U-904			`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021633-002	7572779	2025-10-02	U-904			`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021633-003	7572779	2025-10-02	U-904			`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021633-001	6962908	2021-12-21		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021633-001	7799771	2021-12-21		Drug product	2010-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021633-001	7572779	2025-10-02	U-904			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021633-002	6962908	2021-12-21		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021633-002	7799771	2021-12-21		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021633-002	7572779	2025-10-02	U-904			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021633-003	6962908	2021-12-21		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021633-003	7799771	2021-12-21		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021633-003	7572779	2025-10-02	U-904			`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-001	6962908	2021-12-21		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-001	7799771	2021-12-21		Drug product	2010-10-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-001	7572779	2025-10-02	U-904			`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-002	6962908	2021-12-21		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-002	7799771	2021-12-21		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-002	7572779	2025-10-02	U-904			`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-003	6962908	2021-12-21		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-003	7799771	2021-12-21		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021633-003	7572779	2025-10-02	U-904			`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021633-001	6962908	2021-12-21		Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021633-001	7799771	2021-12-21		Drug product	2010-10-29	`5aa47cf7b7d7…`

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
Femring	ESTRADIOL ACETATE	Millicent US, Inc.	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL ACETATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50288	SUPPL	2017-11-03
5894	SUPPL	2014-08-14
15904	SUPPL	2014-08-13
42244	ORIG	2005-12-01
5893	ORIG	2004-08-25