← FDA DRUG APPROVALS

FDA NDA · NDA060613

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION

neomycin and polymyxin b sulfates and hydrocortisone otic

Sponsor: CASPER PHARMA LLC

APPLICATION
NDA060613
TYPE
NDA
ORIGINAL APPROVAL
1975-05-25
LATEST ACTION
2019-03-15
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

CASPORYN HC · ReferencePrescription
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SUSPENSION/DROPS · OTIC

Approval history

2019-03-15Manufacturing (CMC) · Supplement 14 · standard — Label ↗AP
2017-12-19Labeling · Supplement 13 · standard — Label ↗AP
2000-08-10Labeling · Supplement 9AP
2000-08-10Labeling · Supplement 8AP
1999-07-23Manufacturing (CMC) · Supplement 10AP
1995-02-14Manufacturing (CMC) · Supplement 7AP
1993-03-30Labeling · Supplement 5AP
1988-02-04Labeling · Supplement 4AP
1975-05-25OriginalAP
VIEW ON DRUGS@FDA ↗

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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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