← FDA DRUG APPROVALS

FDA NDA · NDA016619

SUBLIMAZE PRESERVATIVE FREE

Sponsor: RISING

APPLICATION
NDA016619
TYPE
NDA
ORIGINAL APPROVAL
1968-02-19
LATEST ACTION
2025-12-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SUBLIMAZE PRESERVATIVE FREE · ReferencePrescription
FENTANYL CITRATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 56 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 54 · standard — Label ↗AP
2022-08-08Manufacturing (CMC) · Supplement 45 — Letter ↗TA
2022-04-12Labeling · Supplement 52 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 43 · standard — Label ↗AP
2019-01-24Labeling · Supplement 39 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 38 · standard — Letter ↗AP
2016-05-18Manufacturing (CMC) · Supplement 37 · priorityAP
2013-07-03Labeling · Supplement 34 · standard — Letter ↗AP
2003-10-17Labeling · Supplement 32 · standard — Letter ↗AP
1996-04-26Labeling · Supplement 31 · standardAP
1995-02-22Manufacturing (CMC) · Supplement 30 · priorityAP
1993-12-23Labeling · Supplement 29AP
1993-12-23Manufacturing (CMC) · Supplement 27 · priority — Letter ↗AP
1993-12-23Manufacturing (CMC) · Supplement 28 · priorityAP
1993-12-23Manufacturing (CMC) · Supplement 26 · priorityAP
1992-12-07Manufacturing (CMC) · Supplement 24 · priorityAP
1992-10-28Manufacturing (CMC) · Supplement 25 · priorityAP
1991-11-25Manufacturing (CMC) · Supplement 21 · priorityAP
1990-07-05Manufacturing (CMC) · Supplement 23 · priorityAP
1989-09-14Manufacturing (CMC) · Supplement 22 · priorityAP
1987-01-27Labeling · Supplement 20AP
1986-09-05Labeling · Supplement 19AP
1986-09-05Manufacturing (CMC) · Supplement 18 · priorityAP
1985-09-10Labeling · Supplement 17AP
1983-09-07Manufacturing (CMC) · Supplement 14 · priorityAP
1983-03-11Manufacturing (CMC) · Supplement 13 · priorityAP
1982-07-07Labeling · Supplement 12AP
1982-07-07Manufacturing (CMC) · Supplement 11 · priorityAP
1981-02-24Labeling · Supplement 10AP
1981-02-24Manufacturing (CMC) · Supplement 9 · priorityAP
1980-05-23Manufacturing (CMC) · Supplement 6 · priorityAP
1976-11-08Labeling · Supplement 4AP
1968-02-19Type 3 - New Dosage Form · Original · priorityAP
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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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