Lamivudine
These highlights do not include all the information needed to use LAMIVUDINE ORAL SOLUTION safely and effectively. See full prescribing information for LAMIVUDINE ORAL SOLUTION. LAMIVUDINE oral solution, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
ba7ee31e-e8d4-4e17-b27a-d2ce69e3bb00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2021
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamivudine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-055
Application NumberANDA077695
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamivudine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (9)
LAMIVUDINEActive
Quantity: 10 mg in 1 mL
Code: 2T8Q726O95
Classification: ACTIB
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
BANANAInactive
Code: 4AJZ4765R9
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT