Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 AP Yes Yes
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 Type 5 - New Formulation or New Manufacturer STANDARD

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 Manufacturing (CMC)

Label is not available on this site.

01/29/2014 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

02/16/2013 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

04/15/2011 SUPPL-57 Labeling-Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

03/06/1997 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

02/11/1993 SUPPL-51 Labeling

Label is not available on this site.

08/15/1991 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1991 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1987 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

01/10/1986 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

05/16/1984 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1982 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1982 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1981 SUPPL-42 Efficacy

Label is not available on this site.

12/18/1979 SUPPL-39 Efficacy

Label is not available on this site.

08/13/1980 SUPPL-38 Efficacy

Label is not available on this site.

08/13/1980 SUPPL-37 Efficacy

Label is not available on this site.

08/13/1980 SUPPL-35 Efficacy

Label is not available on this site.

12/18/1979 SUPPL-34 Efficacy

Label is not available on this site.

08/13/1980 SUPPL-33 Efficacy

Label is not available on this site.

08/13/1980 SUPPL-32 Efficacy

Label is not available on this site.

12/18/1979 SUPPL-31 Efficacy

Label is not available on this site.

08/13/1980 SUPPL-30 Efficacy

Label is not available on this site.

08/13/1980 SUPPL-29 Efficacy

Label is not available on this site.

12/18/1979 SUPPL-28 Efficacy

Label is not available on this site.

12/18/1979 SUPPL-27 Labeling

Label is not available on this site.

03/09/1978 SUPPL-25 Efficacy

Label is not available on this site.

03/09/1978 SUPPL-24 Efficacy

Label is not available on this site.

03/09/1978 SUPPL-23 Efficacy

Label is not available on this site.

07/22/1980 SUPPL-22 Labeling

Label is not available on this site.

12/18/1979 SUPPL-21 Labeling

Label is not available on this site.

07/22/1980 SUPPL-20 Labeling

Label is not available on this site.

07/22/1980 SUPPL-19 Labeling

Label is not available on this site.

03/09/1978 SUPPL-17 Efficacy

Label is not available on this site.

12/18/1979 SUPPL-15 Labeling

Label is not available on this site.

07/22/1980 SUPPL-11 Labeling

Label is not available on this site.

07/22/1980 SUPPL-10 Labeling

Label is not available on this site.

07/22/1980 SUPPL-9 Labeling

Label is not available on this site.

12/18/1979 SUPPL-8 Labeling

Label is not available on this site.

07/22/1980 SUPPL-2 Labeling

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

CHORIONIC GONADOTROPIN

INJECTABLE;INJECTION; 10,000 UNITS/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL INJECTABLE;INJECTION Prescription Yes AP 017016 FERRING
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL INJECTABLE;INJECTION Prescription Yes AP 017067 FRESENIUS KABI USA
PREGNYL GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL INJECTABLE;INJECTION Prescription Yes AP 017692 ORGANON USA INC

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