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 43.

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 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…`
2019-12-13 00:20 UTC	2019-12	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`74a2ff9319b5…`

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	Exact identifier application applno (NDA): 021367 application number: NDA021367 ndc (product): 72495-202 ndc (product): 72495-201

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