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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MICRO LABS LTD INDIA · Approved 2012-12-14

Drug application

FDA Application #
ANDA201952
Application type
Abbreviated New Drug Application (Generic)
Brand name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Generic name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Active ingredients
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
MICRO LABS LTD INDIA
Manufacturer
Micro Labs Limited
First approval
2012-12-14

Source

Authoritative
Drugs@FDA application overview
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