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TAPENTADOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS UT INC · Approved 2016-03-31

Drug application

FDA Application #
ANDA206657
Application type
Abbreviated New Drug Application (Generic)
Brand name
TAPENTADOL HYDROCHLORIDE
Generic name
Tapentadol Hydrochloride
Active ingredients
TAPENTADOL HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
ACTAVIS LABS UT INC
First approval
2016-03-31

Source

Authoritative
Drugs@FDA application overview
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