Home Applications 022058 Application 022058
Type NDA
Sponsor ENDO PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SUPPRELIN LA HISTRELIN ACETATE IMPLANT;SUBCUTANEOUS 50MG 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 N022058-001 SUPPRELIN LA HISTRELIN ACETATE 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022058-001 8062652 2026-06-16 U-1197
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 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67979-002 SUPPRELIN histrelin acetate Endo Pharmaceuticals Inc. NDA Current 67979-002 SUPPRELIN histrelin acetate Endo Pharmaceuticals Solutions Inc. NDA Current 67979-002 SUPPRELIN histrelin acetate Endo Pharmaceuticals Inc. NDA Current 67979-002 SUPPRELIN histrelin acetate Endo Pharmaceuticals Inc. NDA Current 67979-002 SUPPRELIN histrelin acetate Endo Pharmaceuticals Inc. NDA Current