← FDA DRUG APPROVALS

FDA ANDA · ANDA062423

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

neomycin sulfate, polymyxin b sulfate and hydrocortisone

Sponsor: SANDOZ

APPLICATION
ANDA062423
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-25
LATEST ACTION
2002-12-24
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEPrescription
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SOLUTION/DROPS · OTIC

Approval history

2002-12-24Labeling · Supplement 28AP
2002-12-24Manufacturing (CMC) · Supplement 26AP
2002-12-24Manufacturing (CMC) · Supplement 24AP
2002-12-24Manufacturing (CMC) · Supplement 25AP
2002-12-24Manufacturing (CMC) · Supplement 23AP
2002-12-23Manufacturing (CMC) · Supplement 27AP
1999-02-19Manufacturing (CMC) · Supplement 20AP
1999-02-02Manufacturing (CMC) · Supplement 19AP
1996-04-16Manufacturing (CMC) · Supplement 18AP
1994-03-14Manufacturing (CMC) · Supplement 17AP
1993-12-03Manufacturing (CMC) · Supplement 15AP
1993-09-27Labeling · Supplement 16AP
1991-10-23Labeling · Supplement 14AP
1989-01-27Labeling · Supplement 13AP
1988-11-08Manufacturing (CMC) · Supplement 12AP
1983-08-25OriginalAP
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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