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Details for New Drug Application (NDA): 200503

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NDA 200503 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds, Macleods Pharms Ltd, Lupin Ltd, Amneal Pharms, Zydus Pharms Usa Inc, Sun Pharma Global, Actavis Elizabeth, Aurobindo Pharma Ltd, Northstar Hlthcare, Mylan Pharms Inc, Watson Labs, Ivax Sub Teva Pharms, Sun Pharm Inds Inc, Sandoz, Ipca Labs Ltd, Asta, Aci Healthcare Ltd, Teva, Apotex, Pliva, Par Pharm Inc, Mallinckrodt, Mylan, Accord Hlthcare Inc, Anchen Pharms, Cspc Ouyi Pharm Co, Micro Labs Ltd India, Par Pharm, Atlas Pharms Llc, and Apotex Inc, and is included in thirty-nine NDAs. It is available from sixty suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-five drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for NDA: 200503

Tradename:
TRAMADOL HYDROCHLORIDE
Applicant:
Lupin Ltd
Ingredient:
tramadol hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 200503

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 200503

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200503 ANDA American Health Packaging 68084-963 68084-963-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-963-21) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-963-11)
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200503 ANDA Lupin Pharmaceuticals, Inc. 68180-697 68180-697-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-697-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Aug 29, 2011TE:AB1RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Aug 29, 2011TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Aug 29, 2011TE:AB1RLD:No


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