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FDA ANDA · ANDA065006

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA065006
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-17
LATEST ACTION
1999-03-05
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEPrescription
POLYMYXIN B SULFATE 10,000 UNITS/ML, TRIMETHOPRIM SULFATE EQ 1MG BASE/ML · SOLUTION/DROPS · OPHTHALMIC

Approval history

1999-03-05Manufacturing (CMC) · Supplement 1AP
1998-12-17OriginalLetterAP
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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