Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087506
Company: BAUSCH AND LOMB

Products on ANDA 087506

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPCON	NAPHAZOLINE HYDROCHLORIDE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087506

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/1981	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/1995	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
01/30/1995	SUPPL-23	Labeling		Label is not available on this site.
04/20/1994	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
01/03/1992	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/25/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.