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Generated: April 30, 2017

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Details for New Drug Application (NDA): 091294

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NDA 091294 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. There is one tentative approval for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Summary for NDA: 091294

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 091294

Suppliers and Packaging for NDA: 091294

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
abacavir sulfate
TABLET;ORAL 091294 ANDA Mylan Pharmaceuticals Inc. 0378-4105 0378-4105-91 1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
abacavir sulfate
TABLET;ORAL 091294 ANDA Mylan Institutional Inc. 51079-204 51079-204-06 50 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-204-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Jun 18, 2012TE:ABRLD:No

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