Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013935
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HERPLEX IDOXURIDINE 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
06/11/1963 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
01/10/1997 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/02/1996 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/13/1982 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1981 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1981 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/17/1988 SUPPL-21 Labeling

Label is not available on this site.

04/08/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/08/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/18/1979 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/23/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1977 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/18/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1977 SUPPL-13 Labeling

Label is not available on this site.

04/28/1977 SUPPL-12 Labeling

Label is not available on this site.

07/12/1976 SUPPL-10 Labeling

Label is not available on this site.

03/03/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1976 SUPPL-8 Labeling

Label is not available on this site.

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