Application 021367

Type: NDA
Sponsor: MILLICENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEMRING	ESTRADIOL ACETATE	INSERT, EXTENDED RELEASE;VAGINAL	EQ 0.05MG BASE/24HR	Yes	No
002	FEMRING	ESTRADIOL ACETATE	INSERT, EXTENDED RELEASE;VAGINAL	EQ 0.1MG BASE/24HR	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021367-001	FEMRING	ESTRADIOL ACETATE	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL		RLD	2003-03-20
N021367-002	FEMRING	ESTRADIOL ACETATE	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL		RLD, RS	2003-03-20

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 3 · 88 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	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-5868	Femring	estradiol acetate	Allergan, Inc.	NDA	Current
0023-5869	Femring	estradiol acetate	Allergan, Inc.	NDA	Current
72495-201	Femring	estradiol acetate	Millicent US, Inc.	NDA	Current
72495-201	Femring	estradiol acetate	Millicent US, Inc.	NDA	Current
72495-201	Femring	estradiol acetate	Millicent US, Inc.	NDA	Current
72495-201	Femring	estradiol acetate	Millicent US, Inc.	NDA	Current
72495-202	Femring	estradiol acetate	Millicent US, Inc.	NDA	Current
72495-202	Femring	estradiol acetate	Millicent US, Inc.	NDA	Current
72495-202	Femring	estradiol acetate	Millicent US, Inc.	NDA	Current
72495-202	Femring	estradiol acetate	Millicent US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77579	SUPPL	2024-02-20
77553	SUPPL	2024-02-16
75290	SUPPL	2023-08-25
75273	SUPPL	2023-08-23
75254	SUPPL	2023-08-22
50321	SUPPL	2017-11-07
49366	SUPPL	2017-08-15
49365	SUPPL	2017-08-15
49292	SUPPL	2017-08-09
49291	SUPPL	2017-08-09
27617	SUPPL	2014-06-02
36784	SUPPL	2014-05-30
27616	SUPPL	2009-05-27
15320	SUPPL	2009-05-25
5199	SUPPL	2007-02-23
15319	SUPPL	2007-02-21
27615	SUPPL	2005-08-19
15318	SUPPL	2005-08-19
36783	SUPPL	2005-03-14
5198	SUPPL	2005-03-14
21623	ORIG	2003-07-16
5197	ORIG	2003-03-26
15317	ORIG	2003-03-21