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FDA ANDA · ANDA083590

NAPHAZOLINE HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA083590
TYPE
ANDA
ORIGINAL APPROVAL
1974-08-22
LATEST ACTION
2012-11-30
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

NAPHAZOLINE HYDROCHLORIDEDiscontinued
NAPHAZOLINE HYDROCHLORIDE 0.1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2012-11-30Labeling · Supplement 23 · standardAP
2002-09-30Manufacturing (CMC) · Supplement 21AP
1999-08-25Manufacturing (CMC) · Supplement 19AP
1999-06-07Manufacturing (CMC) · Supplement 20AP
1996-08-08Manufacturing (CMC) · Supplement 18AP
1995-09-14Manufacturing (CMC) · Supplement 16AP
1995-09-14Manufacturing (CMC) · Supplement 14AP
1995-09-14Manufacturing (CMC) · Supplement 12AP
1995-09-14Manufacturing (CMC) · Supplement 10AP
1995-09-14Manufacturing (CMC) · Supplement 9AP
1995-09-14Manufacturing (CMC) · Supplement 17AP
1995-09-14Manufacturing (CMC) · Supplement 15AP
1995-09-14Manufacturing (CMC) · Supplement 13AP
1995-09-14Labeling · Supplement 11AP
1991-07-15Labeling · Supplement 7AP
1991-04-10Labeling · Supplement 8AP
1987-08-07Manufacturing (CMC) · Supplement 6AP
1987-01-15Manufacturing (CMC) · Supplement 5AP
1974-08-22OriginalAP
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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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