MedPath

Standardized Cat Hair

Allergenic Extract

Approved
Approval ID

8417d6d3-b9a6-4091-8521-f9838bb7e587

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 7, 2009

Manufacturers
FDA

Nelco Laboratories, Inc.

DUNS: 054980867

Products 1

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

Standardized Cat Hair

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1121
Application NumberBLA103384
Product Classification
M
Marketing Category
C73585
G
Generic Name
Standardized Cat Hair
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 7, 2009
FDA Product Classification

INGREDIENTS (7)

FELIS CATUS HAIRActive
Quantity: 10000 [BAU] in 1 mL
Code: 1564HD0N96
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Standardized Cat Hair - FDA Drug Approval Details