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FDA ANDA · ANDA211572

POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE

Sponsor: SOMERSET THERAPS LLC

APPLICATION
ANDA211572
TYPE
ANDA
ORIGINAL APPROVAL
2024-08-05
LATEST ACTION
2024-08-05
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

2024-08-05UNKNOWN · Original · standardAP
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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