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FDA ANDA · ANDA207411

AZELASTINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC

APPLICATION
ANDA207411
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-29
LATEST ACTION
2021-04-30
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

AZELASTINE HYDROCHLORIDEPrescription
AZELASTINE HYDROCHLORIDE 0.05% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-04-30Labeling · Supplement 2 · standardAP
2021-04-30Labeling · Supplement 1 · standardAP
2019-03-29UNKNOWN · Original · standardAP
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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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