Home Applications 210132 Application 210132
Type NDA
Sponsor THERAPEUTICSMD INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BIJUVA ESTRADIOL; PROGESTERONE CAPSULE;ORAL 1MG;100MG Yes Yes 002 BIJUVA ESTRADIOL; PROGESTERONE CAPSULE;ORAL 0.5MG;100MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N210132-001 BIJUVA ESTRADIOL; PROGESTERONE 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 N210132-002 BIJUVA ESTRADIOL; PROGESTERONE 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28
Orange Book patents# Current patent rows page 1 of 1 · 39 matching rows.
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 · 73 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 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 5aa47cf7b7d7…
Observed Orange Book patent history# Patent history page 1 of 33 · 1,308 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 N210132-001 10052386 2032-11-21 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 10206932 2032-11-21 U-2439 2019-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 10639375 2032-11-21 Drug product 2020-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 10675288 2032-11-21 U-2439 2020-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 10806740 2032-11-21 U-2439 Drug product 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 11033626 2032-11-21 U-2439 Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 11103513 2032-11-21 U-2439 2021-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 11103516 2032-11-21 Drug product 2021-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 11110099 2032-11-21 Drug product 2021-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 11529360 2032-11-21 Drug product 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 11793819 2032-11-21 U-2439 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 11865179 2032-11-21 Drug substance, Drug product 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 8633178 2032-11-21 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 8846648 2032-11-21 U-2439 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 8846649 2032-11-21 U-2439 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 8987237 2032-11-21 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 8993548 2032-11-21 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 8993549 2032-11-21 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 9006222 2032-11-21 U-2439 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 9114145 2032-11-21 U-2439 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 9114146 2032-11-21 U-2439 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-001 9301920 2032-11-21 U-2439 Drug product 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 10052386 2032-11-21 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 10206932 2032-11-21 U-2439 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 10675288 2032-11-21 U-2439 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 11033626 2032-11-21 U-2439 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 11166963 2032-11-21 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 11793819 2032-11-21 U-2439 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 11865179 2032-11-21 Drug substance, Drug product 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 8633178 2032-11-21 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 8846648 2032-11-21 U-2439 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 8846649 2032-11-21 U-2439 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 8933059 2032-11-21 U-2439 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 8987237 2032-11-21 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 8993548 2032-11-21 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 8993549 2032-11-21 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 9114145 2032-11-21 U-2439 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 9114146 2032-11-21 U-2439 Drug product 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210132-002 9301920 2032-11-21 U-2439 Drug product 2022-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210132-001 10052386 2032-11-21 Drug product 2018-11-19 31067a03dcf5…
Observed Orange Book exclusivity history# NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50261-211 Bijuva estradiol and progesterone TherapeuticsMD, Inc. NDA Current 50261-211 Bijuva estradiol and progesterone TherapeuticsMD, Inc. NDA Current 50261-211 Bijuva estradiol and progesterone TherapeuticsMD, Inc. NDA Current 50261-211 Bijuva estradiol and progesterone TherapeuticsMD, Inc. NDA Current 50261-211 Bijuva estradiol and progesterone TherapeuticsMD, Inc. NDA Current 50261-211 Bijuva estradiol and progesterone TherapeuticsMD, Inc. NDA Current