CETROTIDE از شرکت EMD SERONO INC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CETROTIDE از شرکت EMD SERONO INC

New Drug Application (NDA): 021197

Company: EMD SERONO INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETROTIDE CETRORELIX EQ 0.25MG BASE/ML INJECTABLE;INJECTION Prescription

None

Yes Yes
CETROTIDE CETRORELIX EQ 3MG BASE/ML INJECTABLE;INJECTION Discontinued

None

No 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
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

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
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
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