Home Applications 021197 Application 021197
Type NDA
Sponsor EMD SERONO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CETROTIDE CETRORELIX INJECTABLE;INJECTION EQ 0.25MG BASE/ML Yes Yes 002 CETROTIDE CETRORELIX INJECTABLE;INJECTION EQ 3MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021197-001 CETROTIDE CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 N021197-002 CETROTIDE CETRORELIX ACETATE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021197-001 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 3 · 82 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 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021197-001 6319192 2019-04-23 U-426 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021197-002 6319192 2019-04-23 U-426 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021197-001 6319192 2019-04-23 U-426 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021197-002 6319192 2019-04-23 U-426 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021197-001 6319192 2019-04-23 U-426 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021197-002 6319192 2019-04-23 U-426 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021197-001 6319192 2019-04-23 U-426 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021197-002 6319192 2019-04-23 U-426 ea99ee380514…
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44087-1225 Cetrotide cetrorelix acetate EMD Serono, Inc. NDA Current 44087-1225 Cetrotide cetrorelix acetate EMD Serono, Inc. NDA Current