APPLICATION
ANDA071620
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-07
LATEST ACTION
2023-11-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TEMAZEPAMPrescription
TEMAZEPAM 30MG · CAPSULE · ORAL
TEMAZEPAMPrescription
TEMAZEPAM 15MG · CAPSULE · ORAL
Approval history
2023-11-18Labeling · Supplement 45 · standardAP
2022-08-09Labeling · Supplement 42 · standardAP
2022-08-09Labeling · Supplement 40 · standardAP
2019-09-30Labeling · Supplement 37 · standardAP
2019-09-30Labeling · Supplement 38 · standardAP
2009-03-31Labeling · Supplement 28AP
2002-12-12Manufacturing (CMC) · Supplement 15AP
2001-11-02Manufacturing (CMC) · Supplement 14AP
2001-02-01Labeling · Supplement 13AP
1996-01-18Manufacturing (CMC) · Supplement 12AP
1993-07-09Labeling · Supplement 11AP
1992-12-28Labeling · Supplement 10AP
1992-10-21Manufacturing (CMC) · Supplement 9AP
1991-09-25Manufacturing (CMC) · Supplement 5AP
1990-03-21Bioequivalence · Supplement 8AP
1989-06-07Manufacturing (CMC) · Supplement 3AP
1988-12-20Labeling · Supplement 2AP
1987-10-05Manufacturing (CMC) · Supplement 1AP
1987-08-07OriginalAP
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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