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FDA ANDA · ANDA075840
CRYSELLE
norgestrel and ethinyl estradiol
Sponsor: DURAMED PHARMS BARR
APPLICATION
ANDA075840
TYPE
ANDA
ORIGINAL APPROVAL
2001-11-30
LATEST ACTION
2024-05-31
ROUTE
ORAL, ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CRYSELLEPrescription
ETHINYL ESTRADIOL 0.03MG, NORGESTREL 0.3MG · TABLET · ORAL-21
CRYSELLEPrescription
ETHINYL ESTRADIOL 0.03MG, NORGESTREL 0.3MG · TABLET · ORAL-28
Approval history
2024-05-31Labeling · Supplement 33 · standardAP
2022-04-29Labeling · Supplement 32 · standardAP
2022-04-21Labeling · Supplement 31 · standardAP
2022-04-21Labeling · Supplement 26 · standardAP
2017-08-09Labeling · Supplement 25 · standardAP
2002-11-08Labeling · Supplement 2AP
2002-06-19Manufacturing (CMC) · Supplement 3AP
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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