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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077844

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NDA 077844 describes ABACAVIR SULFATE, which is a drug marketed by Hetero Labs Ltd Iii, Aurobindo Pharma Ltd, Strides Pharma, Apotex Inc, Mylan Pharms Inc, Cipla Ltd, Teva Pharms Usa, and Lupin Ltd, 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 NDA: 077844

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

Pharmacology for NDA: 077844

Suppliers and Packaging for NDA: 077844

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE
abacavir sulfate
TABLET;ORAL 077844 ANDA Aurobindo Pharma Limited 65862-073 65862-073-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-073-60)
ABACAVIR SULFATE
abacavir sulfate
TABLET;ORAL 077844 ANDA American Health Packaging 68084-021 68084-021-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-021-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-021-11)

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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