Home Applications 020578 Application 020578
Type NDA
Sponsor TERSERA THERAPS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZOLADEX GOSERELIN ACETATE IMPLANT;IMPLANTATION EQ 10.8MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020578-001 ZOLADEX GOSERELIN ACETATE EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11
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 · 43 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 2026-09-14 22:38:34 2026-08 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 2 · 45 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.
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 0310-0951 ZOLADEX Goserelin acetate AstraZeneca Pharmaceuticals LP NDA Current 70720-951 ZOLADEX goserelin acetate TerSera Therapeutics LLC NDA Current 70720-951 ZOLADEX goserelin TerSera Therapeutics LLC NDA Current 70720-951 ZOLADEX goserelin TerSera Therapeutics LLC NDA Current 70720-951 ZOLADEX goserelin acetate TerSera Therapeutics LLC NDA Current 70720-951 ZOLADEX goserelin acetate TerSera Therapeutics LLC NDA Current