APPLICATION
ANDA216067
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-29
LATEST ACTION
2022-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NIFEDIPINEPrescription
NIFEDIPINE 60MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEPrescription
NIFEDIPINE 90MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEPrescription
NIFEDIPINE 30MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-10-06Manufacturing (CMC) · Supplement 2 · unknownAP
2022-04-26Manufacturing (CMC) · Supplement 1 · unknownAP
2022-03-29UNKNOWN · 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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