FDA ANDA · ANDA206080

BEPOTASTINE BESILATE

Sponsor: SANDOZ INC

APPLICATION

ANDA206080

TYPE

ANDA

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION

MARKETING STATUS

None (Tentative Approval)

Products

BEPOTASTINE BESILATENone (Tentative Approval)

BEPOTASTINE BESILATE 1.5% · SOLUTION · OPHTHALMIC

2017-06-07UNKNOWN · Original · standardTA

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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.