APPLICATION
NDA011127
TYPE
NDA
ORIGINAL APPROVAL
1959-01-26
LATEST ACTION
2001-04-03
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
COMPAZINE · ReferenceDiscontinued
PROCHLORPERAZINE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
COMPAZINE · ReferenceDiscontinued
PROCHLORPERAZINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
COMPAZINE · ReferenceDiscontinued
PROCHLORPERAZINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
Approval history
1997-05-09Manufacturing (CMC) · Supplement 60 · standardAP
1994-08-11Manufacturing (CMC) · Supplement 59 · standardAP
1992-02-14Manufacturing (CMC) · Supplement 57 · standardAP
1979-08-21Labeling · Supplement 28AP
1959-01-26Type 2 - New Active Ingredient · Original · standardAP
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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