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Details for New Drug Application (NDA): 201107

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NDA 201107 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: 201107

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

Pharmacology for NDA: 201107

Suppliers and Packaging for NDA: 201107

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE
abacavir sulfate
SOLUTION;ORAL 201107 ANDA Camber Pharmaceuticals, Inc. 31722-562 31722-562-24 240 mL in 1 BOTTLE (31722-562-24)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/ML
Approval Date:Sep 26, 2016TE:AARLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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