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BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2022-10-04

Drug application

FDA Application #
ANDA201949
Application type
Abbreviated New Drug Application (Generic)
Brand name
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Generic name
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Active ingredients
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
Marketing status
Prescription
Sponsor
REGCON HOLDINGS
Manufacturer
Florida Pharmaceutical Products, LLC
First approval
2022-10-04

Source

Authoritative
Drugs@FDA application overview
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