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FDA ANDA · ANDA060593

CYCLOSERINE

Sponsor: SANALUZ

APPLICATION
ANDA060593
TYPE
ANDA
ORIGINAL APPROVAL
1964-06-29
LATEST ACTION
2023-03-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SEROMYCINPrescription
CYCLOSERINE 250MG · CAPSULE · ORAL

Approval history

2023-03-03Manufacturing (CMC) · Supplement 44 · unknownAP
2018-11-08Labeling · Supplement 38AP
2018-11-08Labeling · Supplement 36AP
2018-11-08Labeling · Supplement 37AP
2018-11-08Labeling · Supplement 35AP
2002-09-05Manufacturing (CMC) · Supplement 28AP
2002-09-05Manufacturing (CMC) · Supplement 29AP
2001-12-10Labeling · Supplement 27AP
2001-08-21Manufacturing (CMC) · Supplement 26AP
1999-05-04Manufacturing (CMC) · Supplement 25AP
1998-09-30Manufacturing (CMC) · Supplement 23AP
1998-09-02Manufacturing (CMC) · Supplement 24AP
1998-01-26Manufacturing (CMC) · Supplement 22AP
1993-02-23Bioequivalence · Supplement 20AP
1992-04-16Manufacturing (CMC) · Supplement 18AP
1991-09-19Manufacturing (CMC) · Supplement 19AP
1964-06-29OriginalAP
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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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