Home Applications 209627 Application 209627
Type NDA
Sponsor THERAPEUTICSMD INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ANNOVERA ETHINYL ESTRADIOL; SEGESTERONE ACETATE RING;VAGINAL 0.013MG/24HR;0.15MG/24HR Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N209627-001 ANNOVERA ETHINYL ESTRADIOL; SEGESTERONE ACETATE 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209627-001 10632066 2039-02-01 U-2786 2020-04-29 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 N209627-001 12303518 2039-06-21 Drug product 2025-07-09
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 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 10 · 369 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 12303518 2039-06-21 Drug product 2025-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 12303518 2039-06-21 Drug product 2025-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 12303518 2039-06-21 Drug product 2025-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 fd3edfee7708…
Observed Orange Book exclusivity history# 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 Annovera SEGESTERONE ACETATE AND ETHINYL ESTRADIOL Mayne Pharma eb18194f-2021-41fa-8bdf-31e0c0eb646b 2025-04-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209627 application number: NDA209627
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 12822-0313 ANNOVERA SEGESTERONE ACETATE, ETHINYL ESTRADIOL QPharma AB NDA Current 50261-313 ANNOVERA segesterone acetate and ethinyl estradiol TherapeuticsMD, Inc. NDA Current 50261-313 ANNOVERA segesterone acetate and ethinyl estradiol TherapeuticsMD, Inc. NDA Current 50261-313 ANNOVERA segesterone acetate and ethinyl estradiol TherapeuticsMD, Inc. NDA Current 50261-313 ANNOVERA segesterone acetate and ethinyl estradiol TherapeuticsMD, Inc. NDA Current 50261-313 ANNOVERA segesterone acetate and ethinyl estradiol TherapeuticsMD, Inc. NDA Current 50261-313 ANNOVERA segesterone acetate and ethinyl estradiol TherapeuticsMD, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 70973 SUPPL 2022-05-04 55419 ORIG 2018-09-10 55199 ORIG 2018-08-17 55163 ORIG 2018-08-10