Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016636
Company: ADAPT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NARCAN NALOXONE HYDROCHLORIDE 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
NARCAN NALOXONE HYDROCHLORIDE 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
NARCAN NALOXONE HYDROCHLORIDE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
04/13/1971 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2002 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/2002 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/2002 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

02/11/2002 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16636s52s54ltr.pdf
09/06/1996 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/2002 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16636s52s54ltr.pdf
03/20/1995 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1995 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1987 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1987 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1987 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1986 SUPPL-46 Labeling

Label is not available on this site.

06/04/1986 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1986 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1986 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1984 SUPPL-39 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/17/1984 SUPPL-38 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/25/1984 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

10/15/1984 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1985 SUPPL-34 Labeling

Label is not available on this site.

11/17/1983 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/17/1983 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/29/1992 SUPPL-31 Efficacy-New Indication

Label is not available on this site.

06/23/1983 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/1982 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1982 SUPPL-27 Labeling

Label is not available on this site.

05/19/1982 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1981 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1981 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/30/1981 SUPPL-22 Labeling

Label is not available on this site.

04/01/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/23/1981 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/17/1980 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/30/1979 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/23/1979 SUPPL-17 Labeling

Label is not available on this site.

10/20/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1976 SUPPL-15 Labeling

Label is not available on this site.

04/08/1976 SUPPL-14 Labeling

Label is not available on this site.

09/24/1975 SUPPL-13 Labeling

Label is not available on this site.

06/06/1975 SUPPL-11 Labeling

Label is not available on this site.

12/09/1974 SUPPL-9 Labeling

Label is not available on this site.

06/05/1975 SUPPL-8 Labeling

Label is not available on this site.

01/16/1975 SUPPL-7 Labeling

Label is not available on this site.

04/04/1975 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1975 SUPPL-4 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
02/11/2002 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf
02/11/2002 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf

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