APPLICATION
ANDA210012
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-19
LATEST ACTION
2022-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NIFEDIPINEPrescription
NIFEDIPINE 90MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEPrescription
NIFEDIPINE 30MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEPrescription
NIFEDIPINE 60MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-08-11Labeling · Supplement 3 · standardAP
2017-12-19UNKNOWN · 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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