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FDA NDA · NDA215395

LANREOTIDE ACETATE

Sponsor: INVAGEN PHARMS

APPLICATION
NDA215395
TYPE
NDA
ORIGINAL APPROVAL
2021-12-17
LATEST ACTION
2024-09-16
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LANREOTIDE ACETATE · ReferencePrescription
LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) · SOLUTION · SUBCUTANEOUS
LANREOTIDE ACETATE · ReferencePrescription
LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) · SOLUTION · SUBCUTANEOUS
LANREOTIDE ACETATE · ReferencePrescription
LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2024-09-16Efficacy · Supplement 7 · standard — Letter ↗AP
2024-07-11Labeling · Supplement 8 · standard — Letter ↗AP
2021-12-17Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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