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FDA ANDA · ANDA071026

OXAZEPAM

Sponsor: TP ANDA HOLDINGS

APPLICATION
ANDA071026
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-10
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

OXAZEPAMPrescription
OXAZEPAM 10MG · CAPSULE · ORAL
OXAZEPAMPrescription
OXAZEPAM 15MG · CAPSULE · ORAL
OXAZEPAMPrescription
OXAZEPAM 30MG · CAPSULE · ORAL

Approval history

2023-01-17Labeling · Supplement 21 · standardAP
2021-02-05Labeling · Supplement 20 · standardAP
2020-03-17Manufacturing (CMC) · Supplement 18AP
2016-12-16Labeling · Supplement 17 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 11AP
1994-12-23Manufacturing (CMC) · Supplement 10AP
1993-10-05Labeling · Supplement 9AP
1992-04-03Manufacturing (CMC) · Supplement 8AP
1992-04-03Manufacturing (CMC) · Supplement 6AP
1989-04-19Labeling · Supplement 5AP
1988-01-25Manufacturing (CMC) · Supplement 3AP
1988-01-25Manufacturing (CMC) · Supplement 1AP
1988-01-25Manufacturing (CMC) · Supplement 4AP
1987-08-10OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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