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Details for New Drug Application (NDA): 091560

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NDA 091560 describes ABACAVIR SULFATE, which is a drug marketed by Hetero Labs Ltd Iii, Aurobindo Pharma Ltd, Strides Arcolab Ltd, Apotex Inc, Mylan Pharms Inc, Teva Pharms Usa, and Lupin Ltd, and is included in eight NDAs. It is available from nine 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: 091560

Tradename:
ABACAVIR SULFATE
Applicant:
Hetero Labs Ltd Iii
Ingredient:
abacavir sulfate
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 091560

Suppliers and Packaging for NDA: 091560

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE
abacavir sulfate
TABLET;ORAL 091560 ANDA Camber Pharmaceuticals, Inc. 31722-557 31722-557-60 60 TABLET in 1 BOTTLE (31722-557-60)
ABACAVIR SULFATE
abacavir sulfate
TABLET;ORAL 091560 ANDA REMEDYREPACK INC. 52125-956 52125-956-02 30 TABLET in 1 BLISTER PACK (52125-956-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 13, 2013TE:ABRLD:No


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