Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017692
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREGNYL GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/20/1976 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
10/02/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/12/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/28/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/26/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/15/2011 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017692s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017692s021ltr.pdf
12/03/2007 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017692s020ltr.pdf
02/07/2007 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017692s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017692s018ltr.pdf
04/02/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/23/1999 SUPPL-12 Labeling

Label is not available on this site.

02/21/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/18/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/30/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/03/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/19/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/05/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/03/1981 SUPPL-1 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
04/15/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017692s021lbl.pdf
02/07/2007 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017692s018lbl.pdf

PREGNYL

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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