← FDA DRUG APPROVALS

FDA ANDA · ANDA203594

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

Sponsor: WATSON LABS INC

APPLICATION
ANDA203594
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-11
LATEST ACTION
2017-09-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUMPrescription
DROSPIRENONE 3MG,N/A, ETHINYL ESTRADIOL 0.03MG,N/A, LEVOMEFOLATE CALCIUM 0.451MG,0.451MG · TABLET · ORAL

Approval history

2017-09-29Labeling · Supplement 5 · standardAP
2016-10-11UNKNOWN · Original — Letter ↗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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