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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018154
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LONITEN MINOXIDIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
LONITEN MINOXIDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
10/18/1979 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
01/13/2015 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018154Orig1s026ltr.pdf
07/09/2002 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18154slr023ltr.pdf
08/08/2001 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
03/11/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
04/08/1994 SUPPL-20 Labeling

Label is not available on this site.
04/08/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
02/17/1993 SUPPL-18 Labeling

Label is not available on this site.
05/19/1992 SUPPL-17 Labeling

Label is not available on this site.
10/20/1987 SUPPL-16 Labeling

Label is not available on this site.
12/22/1986 SUPPL-15 Labeling

Label is not available on this site.
07/28/1986 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
12/19/1985 SUPPL-12 Labeling

Label is not available on this site.
10/15/1985 SUPPL-9 Labeling

Label is not available on this site.
11/28/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
02/07/1984 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.
06/09/1983 SUPPL-5 Labeling

Label is not available on this site.
02/08/1982 SUPPL-4 Labeling

Label is not available on this site.
12/07/1982 SUPPL-3 Labeling

Label is not available on this site.
04/12/1982 SUPPL-2 Labeling

Label is not available on this site.
04/12/1982 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
01/13/2015 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf
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