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FDA NDA · NDA012583

OPHTHETIC

Sponsor: ALLERGAN

APPLICATION
NDA012583
TYPE
NDA
ORIGINAL APPROVAL
1961-01-23
LATEST ACTION
2003-03-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

OPHTHETIC · ReferenceDiscontinued
PROPARACAINE HYDROCHLORIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2003-03-19Labeling · Supplement 40 · standardAP
2002-06-20Manufacturing (CMC) · Supplement 37 · priority — Letter ↗AP
2002-06-20Labeling · Supplement 28 · standard — Label ↗AP
2002-04-12Manufacturing (CMC) · Supplement 38 · priorityAP
2001-04-12Manufacturing (CMC) · Supplement 35 · priorityAP
2001-03-12Manufacturing (CMC) · Supplement 34 · priorityAP
2000-10-02Manufacturing (CMC) · Supplement 33 · priorityAP
1997-10-17Manufacturing (CMC) · Supplement 32 · priorityAP
1997-09-18Manufacturing (CMC) · Supplement 31 · priorityAP
1997-03-17Manufacturing (CMC) · Supplement 30 · priorityAP
1995-08-03Manufacturing (CMC) · Supplement 27 · priorityAP
1995-05-05Manufacturing (CMC) · Supplement 29 · priorityAP
1993-03-04Manufacturing (CMC) · Supplement 26 · priorityAP
1990-02-05Manufacturing (CMC) · Supplement 24 · priorityAP
1990-02-05Manufacturing (CMC) · Supplement 25 · priorityAP
1989-10-13Manufacturing (CMC) · Supplement 22 · priorityAP
1989-03-20Manufacturing (CMC) · Supplement 23 · priorityAP
1987-04-21Labeling · Supplement 19AP
1982-05-21Manufacturing (CMC) · Supplement 17 · priorityAP
1982-05-21Manufacturing (CMC) · Supplement 18 · priorityAP
1980-05-22Manufacturing (CMC) · Supplement 16 · priorityAP
1979-10-04Manufacturing (CMC) · Supplement 15 · priorityAP
1977-07-14Manufacturing (CMC) · Supplement 11 · priorityAP
1976-09-23Labeling · Supplement 10AP
1976-09-23Labeling · Supplement 8AP
1976-09-10Manufacturing (CMC) · Supplement 9 · priorityAP
1976-09-10Manufacturing (CMC) · Supplement 7 · priorityAP
1975-09-17Labeling · Supplement 6AP
1975-07-01Manufacturing (CMC) · Supplement 5 · priorityAP
1961-01-23Type 3 - New Dosage Form · Original · priorityAP
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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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