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FDA ANDA · ANDA075808
TRI-SPRINTEC
norgestimate and ethinyl estradiol
Sponsor: BARR
APPLICATION
ANDA075808
TYPE
ANDA
ORIGINAL APPROVAL
2003-12-29
LATEST ACTION
2023-11-27
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRI-SPRINTECPrescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
Approval history
2023-11-27Labeling · Supplement 45 · standardAP
2023-11-27Labeling · Supplement 43 · standardAP
2022-04-29Labeling · Supplement 40 · standardAP
2022-01-27Labeling · Supplement 34 · standardAP
2016-04-13Labeling · Supplement 30 · standardAP
2016-04-13Labeling · Supplement 31 · standardAP
2013-02-21Labeling · Supplement 29 · 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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