← FDA DRUG APPROVALS
FDA ANDA · ANDA215675
PREGABALIN EXTENDED RELEASE
pregabalin
Sponsor: SCIEGEN PHARMS
APPLICATION
ANDA215675
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-14
LATEST ACTION
2022-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PREGABALINDiscontinued
PREGABALIN 82.5MG · TABLET, EXTENDED RELEASE · ORAL
PREGABALINDiscontinued
PREGABALIN 165MG · TABLET, EXTENDED RELEASE · ORAL
PREGABALINDiscontinued
PREGABALIN 330MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-09-14UNKNOWN · Original · standardAP
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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