Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018796
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PILOPINE HS PILOCARPINE HYDROCHLORIDE 4% GEL;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
10/01/1984 ORIG-1 Approval Type 3 - New Dosage Form 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
04/17/2008 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018796s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018796s014ltr.pdf
12/10/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/16/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1991 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/31/1991 SUPPL-5 Labeling

Label is not available on this site.

12/13/1988 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/24/1987 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/1988 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
04/17/2008 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018796s014lbl.pdf

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