← FDA DRUG APPROVALS

FDA NDA · NDA019715

DIPENTUM

olsalazine sodium

Sponsor: MYLAN SPCLT VIATRIS

APPLICATION
NDA019715
TYPE
NDA
ORIGINAL APPROVAL
1990-07-31
LATEST ACTION
2024-07-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DIPENTUM · ReferencePrescription
OLSALAZINE SODIUM 250MG · CAPSULE · ORAL

Approval history

2024-07-30Labeling · Supplement 35 · standard — Letter ↗AP
2023-10-24Labeling · Supplement 33 · standard — Letter ↗AP
2022-11-16Labeling · Supplement 32 · standard — Letter ↗AP
2021-11-01Labeling · Supplement 30 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 29 · standard — Label ↗AP
2020-10-07Labeling · Supplement 28 · standard — Letter ↗AP
2009-08-05Labeling · Supplement 27 · standard — Letter ↗AP
2007-07-10Labeling · Supplement 25 · standard — Letter ↗AP
2002-11-12Manufacturing (CMC) · Supplement 22 · priorityAP
2002-08-09Manufacturing (CMC) · Supplement 21 · priority — Letter ↗AP
2002-01-18Labeling · Supplement 18 · standard — Letter ↗AP
2001-02-14Manufacturing (CMC) · Supplement 20 · priorityAP
2000-09-08Labeling · Supplement 19 · standardAP
1999-06-30Labeling · Supplement 17 · standardAP
1996-09-11Manufacturing (CMC) · Supplement 15 · priorityAP
1996-06-12Manufacturing (CMC) · Supplement 11 · priorityAP
1996-06-06Manufacturing (CMC) · Supplement 16 · priorityAP
1996-06-04Manufacturing (CMC) · Supplement 9 · priorityAP
1996-01-31Manufacturing (CMC) · Supplement 12 · priorityAP
1996-01-29Manufacturing (CMC) · Supplement 14 · priorityAP
1995-03-23Manufacturing (CMC) · Supplement 10 · priorityAP
1995-02-08Labeling · Supplement 13 · standardAP
1995-01-26Manufacturing (CMC) · Supplement 4 · priorityAP
1994-09-22Manufacturing (CMC) · Supplement 8 · priorityAP
1994-05-26Manufacturing (CMC) · Supplement 7 · priorityAP
1994-05-24Manufacturing (CMC) · Supplement 6 · priorityAP
1993-12-08Labeling · Supplement 5 · standardAP
1993-08-09Manufacturing (CMC) · Supplement 1 · priorityAP
1993-03-15Labeling · Supplement 3 · standardAP
1993-01-05Labeling · Supplement 2 · standardAP
1990-07-31Type 1 - New Molecular Entity · Original · priorityAP
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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