← FDA DRUG APPROVALS

FDA NDA · NDA211340

KATERZIA

amlodipine

Sponsor: AZURITY

APPLICATION
NDA211340
TYPE
NDA
ORIGINAL APPROVAL
2019-07-08
LATEST ACTION
2021-09-13
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

KATERZIA · ReferencePrescription
AMLODIPINE BENZOATE EQ 1MG BASE/ML · SUSPENSION · ORAL

Approval history

2021-09-13Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2019-07-08Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
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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