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Details for New Drug Application (NDA): 204002

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NDA 204002 describes LAMIVUDINE, which is a drug marketed by Mylan Pharms Inc, Apotex, Lupin Ltd, Aurobindo Pharma Ltd, Apotex Inc, Hetero Labs Ltd V, Silarx Pharms Inc, Hetero Labs Ltd Iii, Strides Pharma, and Teva Pharms, and is included in sixteen NDAs. It is available from fourteen 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. There are nineteen tentative approvals for this compound. Additional details are available on the lamivudine; zidovudine profile page.

Summary for NDA: 204002

Mylan Pharms Inc
Therapeutic Class:Antivirals

Pharmacology for NDA: 204002

Suppliers and Packaging for NDA: 204002

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 204002 ANDA Mylan Pharmaceuticals Inc. 0378-5168 0378-5168-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5168-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 31, 2014TE: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.