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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018239
Company: ALLERGAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPINE DIPIVEFRIN HYDROCHLORIDE 0.1% SOLUTION/DROPS;OPHTHALMIC Discontinued 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
05/02/1980 ORIG-1 Approval Type 3 - New Dosage Form 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
03/19/2003 SUPPL-31 Labeling

Label is not available on this site.
04/12/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.
12/04/2001 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
04/12/2001 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
07/20/2001 SUPPL-25 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18239s25lbl.pdf
10/02/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
03/07/2000 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
10/22/1998 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
04/18/1997 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
08/03/1995 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
01/13/1994 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
10/11/1989 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
10/23/1989 SUPPL-17 Labeling

Label is not available on this site.
10/23/1989 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/09/1988 SUPPL-14 Labeling

Label is not available on this site.
05/14/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
10/16/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
12/02/1983 SUPPL-9 Labeling

Label is not available on this site.
08/13/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
04/09/1987 SUPPL-6 Labeling

Label is not available on this site.
08/12/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
10/22/1980 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
09/02/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
09/02/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
06/05/1980 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
07/20/2001 SUPPL-25 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18239s25lbl.pdf
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