Application 208352

Type: NDA
Sponsor: EVOFEM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHEXXI	LACTIC ACID;CITRIC ACID;POTASSIUM BITARTRATE	GEL;VAGINAL	5G	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208352-001	PHEXX	CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE	1%;1.8%;0.4%	GEL / VAGINAL		RLD, RS	2020-05-22

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208352-001	10568855	2033-03-15	U-1		2020-06-03
N208352-001	11337989	2033-03-15	U-1		2022-09-06
N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15
N208352-001	11992472	2033-03-15	U-1		2024-06-26

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208352-001	PHEXX	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208352-001	PHEXXI	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208352-001	PHEXX	1%;1.8%;0.4%	GEL / VAGINAL	RLD, RS	2020-05-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208352-001	6706276	2024-03-06		Drug product	2020-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208352-001	6706276	2024-03-06		Drug product	2020-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208352-001	6706276	2024-03-06		Drug product	2020-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208352-001	10568855	2033-03-15	U-1		2020-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208352-001	11337989	2033-03-15	U-1		2022-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208352-001	11439610	2033-03-15		Drug substance, Drug product	2022-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208352-001	11992472	2033-03-15	U-1		2024-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208352-001	6706276	2024-03-06		Drug product	2020-06-03	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208352-001	NP	2023-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208352-001	NP	2023-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208352-001	NP	2023-05-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208352-001	NP	2023-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208352-001	NP	2023-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208352-001	NP	2023-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208352-001	NP	2023-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208352-001	NP	2023-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208352-001	NP	2023-05-22	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N208352-001	NP	2023-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208352-001	NP	2023-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208352-001	NP	2023-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208352-001	NP	2023-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208352-001	NP	2023-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208352-001	NP	2023-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208352-001	NP	2023-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208352-001	NP	2023-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208352-001	NP	2023-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208352-001	NP	2023-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208352-001	NP	2023-05-22	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phexx	LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE	Evofem, Inc.	14b01a15-9b47-4be3-bb2e-a2010eab429e	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208352 application number: NDA208352
Phexxi	LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE	Evofem, Inc.	173ff411-7227-47b0-94dc-844e1ebaf14e	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208352 application number: NDA208352 ndc (product): 69751-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69751-100	Phexxi	lactic acid, L-, citric acid monohydrate, and potassium bitartrate	Evofem, Inc.	NDA	Current
69751-100	Phexxi	lactic acid, L-, citric acid monohydrate, and potassium bitartrate	Evofem, Inc.	NDA	Current
69751-100	Phexxi	lactic acid, L-, citric acid monohydrate, and potassium bitartrate	Evofem, Inc.	NDA	Current
69751-100	Phexxi	lactic acid, L-, citric acid monohydrate, and potassium bitartrate	Evofem, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81986	SUPPL	2026-04-14
81992	SUPPL	2025-04-25
70145	SUPPL	2022-02-11
70144	SUPPL	2022-02-10
70134	SUPPL	2022-02-09
65146	ORIG	2020-11-03
63318	ORIG	2020-05-28
63278	ORIG	2020-05-22