Home Applications 204246 Application 204246
Type ANDA
Sponsor SUN PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GANIRELIX ACETATE GANIRELIX ACETATE INJECTABLE;INJECTION 250MCG/0.5ML No No
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 A204246-001 FYREMADEL GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204246-001 AP
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 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55566-1000 Ganirelix Acetate Ganirelix Acetate FERRING PHARMACEUTICALS INC. ANDA Current 55566-1000 Ganirelix Acetate Ganirelix Acetate FERRING PHARMACEUTICALS INC. ANDA Current 55566-1000 Ganirelix Acetate Ganirelix Acetate FERRING PHARMACEUTICALS INC. ANDA Current 55566-1000 Ganirelix Acetate Ganirelix Acetate FERRING PHARMACEUTICALS INC. ANDA Current 55566-1000 Ganirelix Acetate Ganirelix Acetate FERRING PHARMACEUTICALS INC. ANDA Current 55566-1010 Fyremadel ganirelix acetate Ferring Pharmaceuticals Inc. ANDA Current 55566-1010 Fyremadel ganirelix acetate Ferring Pharmaceuticals Inc. ANDA Current 62756-072 Ganirelix Acetate Ganirelix Acetate Sun Pharmaceutical Industries, Inc. ANDA Current