Drugs@FDA: FDA-Approved Drugs
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 | 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. |
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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. |
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02/18/1994 | SUPPL-10 | Supplement |
Label is not available on this site. |
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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. |
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11/03/1988 | SUPPL-7 | Supplement |
Label is not available on this site. |
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04/19/1988 | SUPPL-6 | Supplement |
Label is not available on this site. |
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02/17/1987 | SUPPL-5 | Supplement |
Label is not available on this site. |
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12/24/1986 | SUPPL-4 | Supplement |
Label is not available on this site. |
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11/09/1984 | SUPPL-3 | Supplement |
Label is not available on this site. |
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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 |