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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091606

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NDA 091606 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Silarx Pharms Inc, Apotex, Apotex Inc, Appco Pharma Llc, Cipla Ltd, Eci Pharms Llc, Hetero Labs Ltd V, Lupin Ltd, Mylan Pharms Inc, Hetero Labs Ltd Iii, Pharmacare, Strides Pharma, and Teva Pharms, and is included in twenty-three NDAs. It is available from twenty suppliers. Additional details are available on the LAMIVUDINE profile page.

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

Summary for 091606

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 091606

Suppliers and Packaging for NDA: 091606

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE lamivudine TABLET;ORAL 091606 ANDA Major Pharmaceuticals 0904-6583 0904-6583-04 30 BLISTER PACK in 1 CARTON (0904-6583-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK
LAMIVUDINE lamivudine TABLET;ORAL 091606 ANDA State of Florida DOH Central Pharmacy 53808-0843 53808-0843-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0843-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 2, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Dec 2, 2011TE:ABRLD: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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