Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021197
Company: EMD SERONO INC
Company: EMD SERONO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CETROTIDE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | AP | Yes | Yes |
CETROTIDE | CETRORELIX ACETATE | EQ 3MG BASE/VIAL | POWDER;SUBCUTANEOUS | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/11/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21197ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-197_Cetrotide.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/18/2024 | SUPPL-32 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021197Orig1s032ltr.pdf |
06/04/2024 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021197s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021197Orig1s030ltr.pdf | |
12/04/2023 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s029ltr.pdf | |
12/18/2023 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s017, s022ltr.pdf | |
12/22/2017 | SUPPL-18 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021197Orig1s018ltr.pdf |
12/18/2023 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s017, s022ltr.pdf | |
03/13/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/15/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/29/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/04/2008 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021197s010ltr.pdf | |
04/30/2004 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf |
04/30/2004 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf |
04/30/2004 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf |
12/13/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/04/2024 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021197s030lbl.pdf | |
12/18/2023 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf | |
12/18/2023 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf | |
12/04/2023 | SUPPL-29 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197Orig1s029lbl.pdf | |
04/04/2008 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf | |
08/11/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf |
CETROTIDE
POWDER;SUBCUTANEOUS; EQ 0.25MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | No | AP | 218150 | GLAND |
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | No | AP | 214540 | LIVZON GRP |
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | No | AP | 217776 | QILU |
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | No | AP | 215737 | TEVA PHARMS INC |
CETROTIDE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | Yes | AP | 021197 | EMD SERONO INC |