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TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2024-08-05

Drug application

FDA Application #
ANDA211572
Application type
Abbreviated New Drug Application (Generic)
Brand name
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Generic name
POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
Active ingredients
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
Marketing status
Prescription
Sponsor
SOMERSET THERAPS LLC
Manufacturer
Somerset Therapeutics, LLC
First approval
2024-08-05

Source

Authoritative
Drugs@FDA application overview
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