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Last Updated: May 19, 2024

Details for New Drug Application (NDA): 091294

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NDA 091294 describes ABACAVIR SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Mylan Labs Ltd, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd, and is included in seventeen NDAs. It is available from twelve suppliers. Additional details are available on the ABACAVIR SULFATE profile page.

The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
Summary for 091294
Applicant:Mylan Pharms Inc
Ingredient:abacavir sulfate
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 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 abacavir sulfate TABLET;ORAL 091294 ANDA Mylan Institutional Inc. 51079-204 51079-204-06 50 BLISTER PACK in 1 CARTON (51079-204-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)

Profile for product number 001

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

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