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Details for New Drug Application (NDA): 205217

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NDA 205217 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-four 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: 205217

Tradename:
LAMIVUDINE
Applicant:
Lupin Ltd
Ingredient:
lamivudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 205217

Suppliers and Packaging for NDA: 205217

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE
lamivudine
TABLET;ORAL 205217 ANDA Lupin Pharmaceuticals, Inc. 68180-602 68180-602-01 100 TABLET, FILM COATED in 1 BOTTLE (68180-602-01)
LAMIVUDINE
lamivudine
TABLET;ORAL 205217 ANDA Lupin Pharmaceuticals, Inc. 68180-602 68180-602-07 60 TABLET, FILM COATED in 1 BOTTLE (68180-602-07)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 18, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Dec 18, 2014TE:ABRLD:No


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