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FDA ANDA · ANDA040407

PROCHLORPERAZINE

Sponsor: ABLE

APPLICATION
ANDA040407
TYPE
ANDA
ORIGINAL APPROVAL
2001-07-11
LATEST ACTION
2002-09-05
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued

Products

PROCHLORPERAZINEDiscontinued
PROCHLORPERAZINE 5MG · SUPPOSITORY · RECTAL
PROCHLORPERAZINEDiscontinued
PROCHLORPERAZINE 25MG · SUPPOSITORY · RECTAL
PROCHLORPERAZINEDiscontinued
PROCHLORPERAZINE 2.5MG · SUPPOSITORY · RECTAL

Approval history

2002-09-05Labeling · Supplement 1AP
2001-07-11OriginalAP
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