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FDA ANDA · ANDA075647

MICROGESTIN 1/20

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA075647
TYPE
ANDA
ORIGINAL APPROVAL
2001-02-05
LATEST ACTION
2021-08-31
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MICROGESTIN 1/20Discontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-21
MICROGESTIN FE 1/20Discontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-28

Approval history

2021-08-31Labeling · Supplement 27 · standardAP
2003-07-30Labeling · Supplement 5AP
2002-11-18Manufacturing (CMC) · Supplement 2AP
2002-11-07Manufacturing (CMC) · Supplement 3AP
2001-09-04Manufacturing (CMC) · Supplement 1AP
2001-02-05Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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