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PROTRIPTYLINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SIGMAPHARM LABS LLC · Approved 2010-05-03

Drug application

FDA Application #
ANDA090462
Application type
Abbreviated New Drug Application (Generic)
Brand name
PROTRIPTYLINE HYDROCHLORIDE
Generic name
PROTRIPTYLINE HYDROCHLORIDE
Active ingredients
PROTRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
SIGMAPHARM LABS LLC
Manufacturer
Sigmapharm Laboratories, LLC
First approval
2010-05-03

Source

Authoritative
Drugs@FDA application overview
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