Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012583
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPHTHETIC PROPARACAINE HYDROCHLORIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
01/23/1961 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-40 Labeling

Label is not available on this site.

04/12/2002 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2002 SUPPL-37 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12583s028,s037LTR.pdf
04/12/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/12/2001 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1997 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1997 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1995 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2002 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12583s028,s037LTR.pdf
08/03/1995 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1993 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/05/1990 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/05/1990 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1989 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/21/1987 SUPPL-19 Labeling

Label is not available on this site.

05/21/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/21/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/22/1980 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/04/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1977 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1976 SUPPL-10 Labeling

Label is not available on this site.

09/10/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1976 SUPPL-8 Labeling

Label is not available on this site.

09/10/1976 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1975 SUPPL-6 Labeling

Label is not available on this site.

07/01/1975 SUPPL-5 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
06/20/2002 SUPPL-37 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf
06/20/2002 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf

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