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TRAMADOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IPCA LABS LTD · Approved 2012-11-16

Drug application

FDA Application #

ANDA201973

Application type

Abbreviated New Drug Application (Generic)

Brand name

TRAMADOL HYDROCHLORIDE

Generic name

Tramadol Hydrochloride

Active ingredients

TRAMADOL HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

IPCA LABS LTD

First approval

2012-11-16

Source

Authoritative

Drugs@FDA application overview

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