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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017692
Company: ORGANON USA LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREGNYL GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL INJECTABLE;INJECTION Prescription 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
10/20/1976 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
03/02/2023 SUPPL-43 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017692Orig1s028,s036,s043ltr.pdf
03/02/2023 SUPPL-36 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017692Orig1s028,s036,s043ltr.pdf
03/02/2023 SUPPL-28 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017692Orig1s028,s036,s043ltr.pdf
10/02/2015 SUPPL-27 Supplement

Label is not available on this site.
01/12/2015 SUPPL-25 Supplement

Label is not available on this site.
02/28/2014 SUPPL-24 Supplement

Label is not available on this site.
02/26/2013 SUPPL-23 Supplement

Label is not available on this site.
04/15/2011 SUPPL-21 Supplement 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 Supplement 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 Supplement 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 Supplement

Label is not available on this site.
11/23/1999 SUPPL-12 Supplement

Label is not available on this site.
02/21/1997 SUPPL-11 Supplement

Label is not available on this site.
02/18/1994 SUPPL-10 Supplement

Label is not available on this site.
06/30/1992 SUPPL-9 Supplement

Label is not available on this site.
01/02/1991 SUPPL-8 Supplement

Label is not available on this site.
11/03/1988 SUPPL-7 Supplement

Label is not available on this site.
04/19/1988 SUPPL-6 Supplement

Label is not available on this site.
02/17/1987 SUPPL-5 Supplement

Label is not available on this site.
12/24/1986 SUPPL-4 Supplement

Label is not available on this site.
11/09/1984 SUPPL-3 Supplement

Label is not available on this site.
04/05/1982 SUPPL-2 Supplement

Label is not available on this site.
06/03/1981 SUPPL-1 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/02/2023 SUPPL-43 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
03/02/2023 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
03/02/2023 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
03/02/2023 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
03/02/2023 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
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
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