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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013935
Company: ALLERGAN

Products on NDA 013935

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 013935

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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