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FDA NDA · NDA050417

LUMI-SPORYN

Sponsor: CASPER PHARMA LLC

APPLICATION
NDA050417
TYPE
NDA
ORIGINAL APPROVAL
1971-05-10
LATEST ACTION
2020-05-21
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

LUMI-SPORYN · ReferencePrescription
BACITRACIN ZINC 400 UNITS/GM, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2020-05-21Labeling · Supplement 12 · standard — Label ↗AP
2004-04-30Labeling · Supplement 11 · standard — Label ↗AP
1999-04-19Manufacturing (CMC) · Supplement 10AP
1999-02-23Manufacturing (CMC) · Supplement 9AP
1995-02-09Manufacturing (CMC) · Supplement 8AP
1994-05-10Labeling · Supplement 4AP
1993-09-22Manufacturing (CMC) · Supplement 7AP
1993-03-23Manufacturing (CMC) · Supplement 6AP
1992-08-10Manufacturing (CMC) · Supplement 5AP
1971-05-10UNKNOWN · Original · unknownAP
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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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