← FDA DRUG APPROVALS

FDA ANDA · ANDA062488

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

neomycin sulfate, polymyxin b sulfate and hydrocortisone

Sponsor: SANDOZ

APPLICATION
ANDA062488
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-06
LATEST ACTION
2002-12-24
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SUSPENSION/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 · SUSPENSION/DROPS · OTIC

Approval history

2002-12-24Manufacturing (CMC) · Supplement 18AP
2002-12-24Manufacturing (CMC) · Supplement 16AP
2002-12-24Manufacturing (CMC) · Supplement 14AP
2002-12-24Manufacturing (CMC) · Supplement 17AP
2002-12-24Manufacturing (CMC) · Supplement 15AP
2002-12-24Labeling · Supplement 21AP
2002-12-23Manufacturing (CMC) · Supplement 20AP
1999-02-19Manufacturing (CMC) · Supplement 12AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1996-04-16Manufacturing (CMC) · Supplement 10AP
1994-05-25Labeling · Supplement 8AP
1994-03-14Manufacturing (CMC) · Supplement 7AP
1992-11-18Labeling · Supplement 6AP
1991-02-28Labeling · Supplement 5AP
1989-01-27Manufacturing (CMC) · Supplement 3AP
1989-01-10Manufacturing (CMC) · Supplement 4AP
1985-11-06Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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