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FDA NDA · NDA021690

ORTHO TRI-CYCLEN 28

Sponsor: ORTHO MCNEIL PHARM

APPLICATION
NDA021690
TYPE
NDA
ORIGINAL APPROVAL
2005-05-13
LATEST ACTION
2015-05-01
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ORTHO TRI-CYCLEN 28Prescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
ORTHO TRI-CYCLEN 21Prescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-21

Approval history

2015-05-01Labeling · Supplement 1 · standard — Letter ↗AP
2005-05-13Type 6 - New Indication (no longer used) · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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