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FDA ANDA · ANDA210838

NIFEDIPINE

Sponsor: SPIL

APPLICATION
ANDA210838
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-16
LATEST ACTION
2019-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

NIFEDIPINEDiscontinued
NIFEDIPINE 90MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEDiscontinued
NIFEDIPINE 30MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEDiscontinued
NIFEDIPINE 60MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-04-16UNKNOWN · 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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