FDA NDA · NDA018206

LO/OVRAL FE

Sponsor: CADENCE HEALTH

APPLICATION

NDA018206

TYPE

NDA

ORIGINAL APPROVAL

1979-07-26

LATEST ACTION

2022-04-29

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

LO/OVRAL FEPrescription

ETHINYL ESTRADIOL 0.03MG,0.3MG, LEVONORGESTREL 75MG, FERROUS FUMARATE · TABLET · ORAL

2022-04-29Labeling · Supplement 22 · standard — Label ↗AP

2017-10-18Labeling · Supplement 20 · standard — Letter ↗AP

2017-08-09Labeling · Supplement 21 · standard — Label ↗AP

2002-03-06Manufacturing (CMC) · Supplement 14AP

2001-05-24Labeling · Supplement 13 · standardAP

1995-05-03Labeling · Supplement 11 · standardAP

1994-11-29Labeling · Supplement 10 · standardAP

1988-06-08Manufacturing (CMC) · Supplement 9AP

1985-05-14Manufacturing (CMC) · Supplement 7AP

1984-08-23Labeling · Supplement 6AP

1984-02-10Manufacturing (CMC) · Supplement 5AP

1983-02-17Labeling · Supplement 4AP

1982-12-07Manufacturing (CMC) · Supplement 1AP

1979-07-26Type 3 - New Dosage Form · 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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