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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018024
Company: PAR PHARM INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUBAIN NALBUPHINE HYDROCHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
NUBAIN NALBUPHINE HYDROCHLORIDE 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
05/15/1979 ORIG-1 Approval Type 1 - New Molecular Entity 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
12/15/2023 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018024s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018024Orig1s043ltr.pdf
10/07/2019 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018024s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018024Orig1s042ltr.pdf
12/16/2016 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018024s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018024Orig1s041ltr.pdf
08/23/2005 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018024s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018024s040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018024_S040_NUBAIN.pdf
10/25/2002 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.
01/15/2002 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.
04/16/2002 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
04/30/2003 SUPPL-36 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18024slr036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018024_S036_NUBAIN_INJECTION.pdf
12/15/1995 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.
10/15/1993 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.
11/02/1994 SUPPL-32 Labeling

Label is not available on this site.
10/19/1990 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
11/10/1988 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.
12/07/1987 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
11/10/1988 SUPPL-27 Labeling

Label is not available on this site.
08/04/1987 SUPPL-26 Labeling

Label is not available on this site.
03/03/1988 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/28/1984 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.
09/13/1984 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
09/13/1984 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
09/17/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
08/17/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
08/17/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
02/16/1983 SUPPL-17 Labeling

Label is not available on this site.
10/23/1986 SUPPL-16 Efficacy-New Indication

Label is not available on this site.
03/02/1984 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
03/02/1984 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.
05/20/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
05/20/1982 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/27/1982 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
05/27/1982 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/01/1981 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
02/20/1981 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
02/21/1980 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/24/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
06/28/1979 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
12/15/2023 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018024s043lbl.pdf
10/07/2019 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018024s042lbl.pdf
12/16/2016 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018024s041lbl.pdf
08/23/2005 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018024s040lbl.pdf
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