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FDA ANDA · ANDA075671

MEGESTROL ACETATE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA075671
TYPE
ANDA
ORIGINAL APPROVAL
2001-07-25
LATEST ACTION
2020-05-19
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

MEGESTROL ACETATEPrescription
MEGESTROL ACETATE 40MG/ML · SUSPENSION · ORAL

Approval history

2020-05-19Labeling · Supplement 23 · standardAP
2013-01-16Labeling · Supplement 16 · standardAP
2004-05-04Labeling · Supplement 11AP
2004-02-23Labeling · Supplement 8AP
2003-08-14Labeling · Supplement 7AP
2002-10-01Manufacturing (CMC) · Supplement 1AP
2001-07-25OriginalLetterAP
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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