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 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 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 2 of 2 · 79 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 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…2020-12-22 03:56 UTC 2020-12 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 e64feba35796…2022-09-29 23:25 UTC 2022-09 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210132-001 BIJUVA 1MG;100MG CAPSULE / ORAL RLD, RS 2018-10-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210132-002 BIJUVA 0.5MG;100MG CAPSULE / ORAL RLD 2021-12-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 36 · 1,425 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N210132-001 10052386 2032-11-21 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 10206932 2032-11-21 U-2439 2019-03-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 10639375 2032-11-21 Drug product 2020-05-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 10675288 2032-11-21 U-2439 2020-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 10806740 2032-11-21 U-2439 Drug product 2020-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 11033626 2032-11-21 U-2439 Drug product 2021-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 11103513 2032-11-21 U-2439 2021-09-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 11103516 2032-11-21 Drug product 2021-09-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 11110099 2032-11-21 Drug product 2021-09-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 11529360 2032-11-21 Drug product 2022-12-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 11793819 2032-11-21 U-2439 2023-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 11865179 2032-11-21 Drug substance, Drug product 2024-02-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 8633178 2032-11-21 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 8846648 2032-11-21 U-2439 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 8846649 2032-11-21 U-2439 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 8987237 2032-11-21 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 8993548 2032-11-21 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 8993549 2032-11-21 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 9006222 2032-11-21 U-2439 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 9114145 2032-11-21 U-2439 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 9114146 2032-11-21 U-2439 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-001 9301920 2032-11-21 U-2439 Drug product 2018-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 10052386 2032-11-21 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 10206932 2032-11-21 U-2439 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 10675288 2032-11-21 U-2439 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 11033626 2032-11-21 U-2439 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 11166963 2032-11-21 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 11793819 2032-11-21 U-2439 2023-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 11865179 2032-11-21 Drug substance, Drug product 2024-02-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 8633178 2032-11-21 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 8846648 2032-11-21 U-2439 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 8846649 2032-11-21 U-2439 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 8933059 2032-11-21 U-2439 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 8987237 2032-11-21 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 8993548 2032-11-21 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 8993549 2032-11-21 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 9114145 2032-11-21 U-2439 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 9114146 2032-11-21 U-2439 Drug product 2022-01-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210132-002 9301920 2032-11-21 U-2439 Drug product 2022-01-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 N210132-001 10052386 2032-11-21 Drug product 2018-11-19 84e616aacf4f…
Observed Orange Book exclusivity history# 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 · 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