FDA.reportPublic FDA data

Asparaginase Lyophilized

Manufacturer
SAJJALA BIO LABS PRIVATE LIMITED
Effective date
2021-05-04
Label type
BULK INGREDIENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:59

Label at a glance#

ProductAsparaginase Lyophilized
Active ingredientASPARAGINASE
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL – BULK PRODUCT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAJJALA BIO LABS PRIVATE LIMITED
Plot No. 8, ALEAP Industrial Estate Gajularamaram, Quthbullapur, Medchal-Malkajgiri, 500090, India (IND)

PRODUCT: Asparaginase Lyophilized 50,000 (IU) / Vial


NDC#: 73019-0200-2

CAUTION: FOR FURTHER MANUFACTURING, OR PROCESSING
VETERINARY RX ONLY

SAJJALA BIO LABS PRIVATE LIMITED Plot No. 8, ALEAP Industrial Estate Gajularamaram, Quthbullapur, Medchal-Malkajgiri, 500090, India (IND) PRODUCT: Asparaginase Lyophilized 50,00...SAJJALA BIO LABS PRIVATE LIMITED Plot No. 8, ALEAP Industrial Estate Gajularamaram, Quthbullapur, Medchal-Malkajgiri, 500090, India (IND) PRODUCT: Asparaginase Lyophilized 50,00...

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ecb42c05-a297-4ddf-bbd1-f324912e7232Product name120220125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73019-0200-1Asparaginase Lyophilized10000 [iU] in 1 VIALPOWDER100002
73019-0200-2Asparaginase Lyophilized50000 [iU] in 1 VIALPOWDER500002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73019-0200ASPARAGINASE LYOPHILIZED POWDER [SAJJALA BIO LABS PRIVATE LIMITED]22 package rows20210430_9e69aefe-cd91-4335-8f18-9f510266d77c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73019-020073019-0200-1, 73019-0200-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARAGINASEG4FQ3CKY5RACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.