Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017067
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 5,000 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL INJECTABLE;INJECTION Prescription None No No
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 20,000 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 15,000 UNITS/VIAL 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
03/05/1973 ORIG-1 Approval N/A

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/2015 SUPPL-62 Supplement

Label is not available on this site.

01/29/2014 SUPPL-60 Supplement

Label is not available on this site.

02/16/2013 SUPPL-59 Supplement

Label is not available on this site.

04/15/2011 SUPPL-57 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017067s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017067s057ltr.pdf
11/14/2002 SUPPL-54 Supplement

Label is not available on this site.

03/06/1997 SUPPL-52 Supplement

Label is not available on this site.

02/11/1993 SUPPL-51 Supplement

Label is not available on this site.

08/15/1991 SUPPL-50 Supplement

Label is not available on this site.

08/14/1991 SUPPL-49 Supplement

Label is not available on this site.

08/05/1987 SUPPL-47 Supplement

Label is not available on this site.

01/10/1986 SUPPL-46 Supplement

Label is not available on this site.

05/16/1984 SUPPL-45 Supplement

Label is not available on this site.

10/20/1982 SUPPL-44 Supplement

Label is not available on this site.

02/03/1982 SUPPL-43 Supplement

Label is not available on this site.

07/13/1981 SUPPL-42 Supplement

Label is not available on this site.

12/18/1979 SUPPL-39 Supplement

Label is not available on this site.

08/13/1980 SUPPL-38 Supplement

Label is not available on this site.

08/13/1980 SUPPL-37 Supplement

Label is not available on this site.

08/13/1980 SUPPL-35 Supplement

Label is not available on this site.

12/18/1979 SUPPL-34 Supplement

Label is not available on this site.

08/13/1980 SUPPL-33 Supplement

Label is not available on this site.

08/13/1980 SUPPL-32 Supplement

Label is not available on this site.

12/18/1979 SUPPL-31 Supplement

Label is not available on this site.

08/13/1980 SUPPL-30 Supplement

Label is not available on this site.

08/13/1980 SUPPL-29 Supplement

Label is not available on this site.

12/18/1979 SUPPL-28 Supplement

Label is not available on this site.

12/18/1979 SUPPL-27 Supplement

Label is not available on this site.

03/09/1978 SUPPL-25 Supplement

Label is not available on this site.

03/09/1978 SUPPL-24 Supplement

Label is not available on this site.

03/09/1978 SUPPL-23 Supplement

Label is not available on this site.

07/22/1980 SUPPL-22 Supplement

Label is not available on this site.

12/18/1979 SUPPL-21 Supplement

Label is not available on this site.

07/22/1980 SUPPL-20 Supplement

Label is not available on this site.

07/22/1980 SUPPL-19 Supplement

Label is not available on this site.

03/09/1978 SUPPL-17 Supplement

Label is not available on this site.

12/18/1979 SUPPL-15 Supplement

Label is not available on this site.

07/22/1980 SUPPL-11 Supplement

Label is not available on this site.

07/22/1980 SUPPL-10 Supplement

Label is not available on this site.

07/22/1980 SUPPL-9 Supplement

Label is not available on this site.

12/18/1979 SUPPL-8 Supplement

Label is not available on this site.

07/22/1980 SUPPL-2 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/15/2011 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017067s057lbl.pdf

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