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PROMETH VC W/ CODEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL RX · Approved 1984-10-31

Drug application

FDA Application #
ANDA088764
Application type
Abbreviated New Drug Application (Generic)
Brand name
PROMETH VC W/ CODEINE
Generic name
Codeine Phosphate
Active ingredients
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Dosage form
SYRUP
Route
ORAL
Marketing status
Discontinued
Sponsor
CHARTWELL RX
First approval
1984-10-31

Source

Authoritative
Drugs@FDA application overview
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