← FDA DRUG APPROVALS
FDA ANDA · ANDA075288
LOW-OGESTREL
norgestrel and ethinyl estradiol
Sponsor: DR REDDYS LABS SA
APPLICATION
ANDA075288
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-28
LATEST ACTION
2022-04-29
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
LOW-OGESTREL-21Discontinued
ETHINYL ESTRADIOL 0.03MG, NORGESTREL 0.3MG · TABLET · ORAL-21
LOW-OGESTREL-28Prescription
ETHINYL ESTRADIOL 0.03MG, NORGESTREL 0.3MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 24 · standardAP
2022-02-28Labeling · Supplement 23 · standardAP
2017-08-09Labeling · Supplement 21 · standardAP
2005-06-24Labeling · Supplement 8AP
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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