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TRAMADOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2011-12-30

Drug application

FDA Application #

ANDA091607

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

Discontinued

Sponsor

SUN PHARM

Manufacturer

Sun Pharmaceutical Industries, Inc.

First approval

2011-12-30

Source

Authoritative

Drugs@FDA application overview

Machine

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