← FDA DRUG APPROVALS

FDA NDA · NDA215422

LYVISPAH

baclofen

Sponsor: STRIDES PHARMA INTL

APPLICATION
NDA215422
TYPE
NDA
ORIGINAL APPROVAL
2021-11-22
LATEST ACTION
2021-11-22
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued

Products

LYVISPAH · ReferenceDiscontinued
BACLOFEN 10MG/PACKET · GRANULE · ORAL
LYVISPAH · ReferenceDiscontinued
BACLOFEN 20MG/PACKET · GRANULE · ORAL
LYVISPAH · ReferenceDiscontinued
BACLOFEN 5MG/PACKET · GRANULE · ORAL

Approval history

2021-11-22Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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