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FDA Approval

Lamivudine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 8, 2021
Labeling Type
Human Prescription Drug Label
Lamivudine(10 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Aurobindo Pharma Limited

Aurobindo Pharma Limited

918917642

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lamivudine

Product Details

NDC Product Code
65862-055
Application Number
ANDA077695
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 8, 2021
Code: 2T8Q726O95Class: ACTIBQuantity: 10 mg in 1 mL
STRAWBERRYInactive
Code: 4J2TY8Y81VClass: IACT
BANANAInactive
Code: 4AJZ4765R9Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
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