Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010656
Company: MERCK

Products on NDA 010656

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLOROPRYL	ISOFLUROPHATE	0.025%	OINTMENT;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010656

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/1957	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
07/10/1995	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
04/30/1993	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
09/30/1992	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
12/28/1990	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
01/19/1990	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/04/1990	SUPPL-17	Labeling		Label is not available on this site.
12/04/1987	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/30/1989	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
02/12/1986	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/06/1984	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/27/1981	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/19/1981	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/26/1987	SUPPL-10	Labeling		Label is not available on this site.
01/09/1978	SUPPL-9	Labeling		Label is not available on this site.