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Serving leading biopharmaceutical companies globally:

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Dow
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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201570

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NDA 201570 describes ABACAVIR SULFATE, which is a drug marketed by Hetero Labs Ltd Iii, Apotex Inc, Aurobindo Pharma Ltd, Mylan Pharms Inc, Strides Pharma, Cipla Ltd, Lupin Ltd, and Teva Pharms Usa, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the ABACAVIR SULFATE profile page.

The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Summary for 201570

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 201570

Suppliers and Packaging for NDA: 201570

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 201570 ANDA Major Pharmaceuticals 0904-6523 0904-6523-04 30 BLISTER PACK in 1 CARTON (0904-6523-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 201570 ANDA Major Pharmaceuticals 0904-6523 0904-6523-06 50 BLISTER PACK in 1 CARTON (0904-6523-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Dec 17, 2012TE:ABRLD:No


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