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TRAMADOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN LTD · Approved 2011-08-29

Drug application

FDA Application #
ANDA200503
Application type
Abbreviated New Drug Application (Generic)
Brand name
TRAMADOL HYDROCHLORIDE
Generic name
TRAMADOL HYDROCHLORIDE
Active ingredients
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
LUPIN LTD
Manufacturer
Lupin Pharmaceuticals, Inc.
First approval
2011-08-29

Source

Authoritative
Drugs@FDA application overview
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