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PROMETHAZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: KVK TECH · Approved 2006-07-31

Drug application

FDA Application #
ANDA040712
Application type
Abbreviated New Drug Application (Generic)
Brand name
PROMETHAZINE HYDROCHLORIDE
Generic name
PROMETHAZINE HYDROCHLORIDE
Active ingredients
PROMETHAZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
KVK TECH
Manufacturer
KVK-Tech, Inc.
First approval
2006-07-31

Source

Authoritative
Drugs@FDA application overview
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