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Serving 500+ biopharmaceutical companies globally:

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Dow
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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204528

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NDA 204528 describes LAMIVUDINE, which is a drug marketed by Mylan Pharms Inc, Apotex, Lupin Ltd, Cipla Ltd, Aurobindo Pharma Ltd, Apotex Inc, Hetero Labs Ltd V, Silarx Pharms Inc, Appco Pharma Llc, Centaur Pharms Pvt, Pharmacare, Hetero Labs Ltd Iii, Strides Pharma, and Teva Pharms, and is included in twenty-three NDAs. It is available from nineteen suppliers. Additional details are available on the LAMIVUDINE profile page.

The generic ingredient in LAMIVUDINE is lamivudine; zidovudine. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

Summary for NDA: 204528

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

Pharmacology for NDA: 204528

Suppliers and Packaging for NDA: 204528

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE
lamivudine
TABLET;ORAL 204528 ANDA Mylan Pharmaceuticals Inc. 0378-5169 0378-5169-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5169-91)
LAMIVUDINE
lamivudine
TABLET;ORAL 204528 ANDA Mylan Pharmaceuticals Inc. 0378-5170 0378-5170-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5170-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Mar 4, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Mar 4, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Deloitte
Medtronic
Cipla
Covington
Citi
Chubb
Novartis
Baxter
Federal Trade Commission

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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