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FDA ANDA · ANDA087506

OPCON

Sponsor: BAUSCH AND LOMB

APPLICATION
ANDA087506
TYPE
ANDA
ORIGINAL APPROVAL
1981-12-01
LATEST ACTION
1995-07-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

OPCONDiscontinued
NAPHAZOLINE HYDROCHLORIDE 0.1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

1995-07-07Manufacturing (CMC) · Supplement 24AP
1995-01-30Labeling · Supplement 23AP
1994-04-20Manufacturing (CMC) · Supplement 12AP
1994-04-20Manufacturing (CMC) · Supplement 19AP
1994-04-20Manufacturing (CMC) · Supplement 17AP
1994-04-20Manufacturing (CMC) · Supplement 15AP
1994-04-20Manufacturing (CMC) · Supplement 21AP
1994-04-20Manufacturing (CMC) · Supplement 13AP
1994-04-20Manufacturing (CMC) · Supplement 18AP
1994-04-20Manufacturing (CMC) · Supplement 16AP
1994-04-20Manufacturing (CMC) · Supplement 22AP
1994-04-20Manufacturing (CMC) · Supplement 14AP
1994-04-20Manufacturing (CMC) · Supplement 20AP
1992-01-03Manufacturing (CMC) · Supplement 10AP
1988-03-25Manufacturing (CMC) · Supplement 5AP
1981-12-01OriginalAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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