Home Applications 022057 Application 022057
Type NDA
Sponsor FERRING Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENDOMETRIN PROGESTERONE INSERT;VAGINAL 100MG Yes Yes
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 N022057-001 ENDOMETRIN PROGESTERONE 100MG INSERT / VAGINAL AB RLD, RS 2007-06-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022057-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL AB RLD, RS 2007-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL AB RLD, RS 2007-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL AB RLD, RS 2007-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022057-001 ENDOMETRIN 100MG INSERT / VAGINAL RLD, RS 2007-06-21 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 N022057-001 AB 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022057-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022057-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022057-001 AB 1 a50c72e98297…
Observed Orange Book patent 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 · 2 matching rows.
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 55566-6500 ENDOMETRIN Progesterone Ferring Pharmaceuticals Inc. NDA Current 55566-6500 ENDOMETRIN Progesterone Ferring Pharmaceuticals Inc. NDA Current 55566-6500 ENDOMETRIN Progesterone Ferring Pharmaceuticals Inc. NDA Current 55566-6500 ENDOMETRIN Progesterone Ferring Pharmaceuticals Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 21921 ORIG 2009-11-19 6787 SUPPL 2009-06-08 38157 SUPPL 2008-02-28 6786 SUPPL 2008-02-27 6785 ORIG 2007-07-05 38156 ORIG 2007-06-27