Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017016
Company: FERRING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 20,000 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 5,000 UNITS/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 2,000 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 15,000 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC 2,000 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
01/15/1974 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
01/09/2017 SUPPL-163 Manufacturing (CMC)

Label is not available on this site.

03/07/2016 SUPPL-160 Manufacturing (CMC)

Label is not available on this site.

10/21/2015 SUPPL-159 Manufacturing (CMC)

Label is not available on this site.

05/02/2014 SUPPL-158 Manufacturing (CMC)

Label is not available on this site.

04/15/2011 SUPPL-156 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017016s156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017016s156ltr.pdf
06/10/2008 SUPPL-155 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/21/2002 SUPPL-150 Labeling

Label is not available on this site.

01/13/1999 SUPPL-148 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1998 SUPPL-147 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1998 SUPPL-146 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1997 SUPPL-145 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1996 SUPPL-144 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1996 SUPPL-143 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1993 SUPPL-142 Labeling

Label is not available on this site.

03/22/1994 SUPPL-141 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1993 SUPPL-140 Labeling

Label is not available on this site.

09/05/1991 SUPPL-139 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1991 SUPPL-138 Labeling

Label is not available on this site.

02/06/1990 SUPPL-137 Labeling

Label is not available on this site.

02/16/1990 SUPPL-136 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1988 SUPPL-135 Manufacturing (CMC)

Label is not available on this site.

01/05/1988 SUPPL-134 Labeling

Label is not available on this site.

05/12/1986 SUPPL-133 Manufacturing (CMC)

Label is not available on this site.

12/27/1984 SUPPL-132 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/15/1985 SUPPL-131 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/18/1984 SUPPL-130 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/10/1982 SUPPL-127 Labeling

Label is not available on this site.

10/20/1982 SUPPL-126 Labeling

Label is not available on this site.

04/15/1981 SUPPL-123 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1981 SUPPL-121 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1981 SUPPL-116 Labeling

Label is not available on this site.

01/05/1981 SUPPL-113 Labeling

Label is not available on this site.

11/07/1980 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

03/11/1980 SUPPL-107 Labeling

Label is not available on this site.

03/11/1980 SUPPL-106 Labeling

Label is not available on this site.

03/11/1980 SUPPL-105 Labeling

Label is not available on this site.

03/11/1980 SUPPL-104 Labeling

Label is not available on this site.

03/11/1980 SUPPL-103 Labeling

Label is not available on this site.

03/11/1980 SUPPL-102 Labeling

Label is not available on this site.

03/11/1980 SUPPL-101 Labeling

Label is not available on this site.

03/11/1980 SUPPL-100 Labeling

Label is not available on this site.

10/02/1979 SUPPL-99 Labeling

Label is not available on this site.

10/02/1979 SUPPL-98 Labeling

Label is not available on this site.

10/02/1979 SUPPL-97 Labeling

Label is not available on this site.

10/02/1979 SUPPL-96 Labeling

Label is not available on this site.

10/02/1979 SUPPL-95 Labeling

Label is not available on this site.

10/02/1979 SUPPL-94 Labeling

Label is not available on this site.

10/02/1979 SUPPL-93 Labeling

Label is not available on this site.

10/02/1979 SUPPL-91 Labeling

Label is not available on this site.

10/02/1979 SUPPL-90 Labeling

Label is not available on this site.

10/02/1979 SUPPL-89 Labeling

Label is not available on this site.

10/02/1979 SUPPL-88 Labeling

Label is not available on this site.

10/02/1979 SUPPL-87 Labeling

Label is not available on this site.

10/02/1979 SUPPL-86 Labeling

Label is not available on this site.

10/02/1979 SUPPL-85 Labeling

Label is not available on this site.

10/02/1979 SUPPL-84 Labeling

Label is not available on this site.

10/02/1979 SUPPL-83 Labeling

Label is not available on this site.

10/02/1979 SUPPL-82 Labeling

Label is not available on this site.

10/02/1979 SUPPL-81 Labeling

Label is not available on this site.

10/02/1979 SUPPL-80 Labeling

Label is not available on this site.

10/02/1979 SUPPL-79 Labeling

Label is not available on this site.

10/02/1979 SUPPL-78 Labeling

Label is not available on this site.

10/02/1979 SUPPL-77 Labeling

Label is not available on this site.

10/02/1979 SUPPL-76 Labeling

Label is not available on this site.

10/02/1979 SUPPL-75 Labeling

Label is not available on this site.

10/02/1979 SUPPL-74 Labeling

Label is not available on this site.

10/03/1979 SUPPL-73 Labeling

Label is not available on this site.

10/03/1979 SUPPL-72 Labeling

Label is not available on this site.

10/03/1979 SUPPL-71 Labeling

Label is not available on this site.

10/03/1979 SUPPL-70 Labeling

Label is not available on this site.

03/19/1979 SUPPL-68 Labeling

Label is not available on this site.

01/02/1979 SUPPL-67 Labeling

Label is not available on this site.

09/21/1978 SUPPL-66 Labeling

Label is not available on this site.

12/13/1978 SUPPL-65 Labeling

Label is not available on this site.

05/25/1978 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1976 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1976 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1976 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1976 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1976 SUPPL-58 Labeling

Label is not available on this site.

01/16/1976 SUPPL-57 Labeling

Label is not available on this site.

01/15/1976 SUPPL-56 Labeling

Label is not available on this site.

01/16/1975 SUPPL-55 Labeling

Label is not available on this site.

01/15/1976 SUPPL-54 Labeling

Label is not available on this site.

06/10/1975 SUPPL-50 Labeling

Label is not available on this site.

06/26/1975 SUPPL-1 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-156 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017016s156lbl.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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