Para Grass Pollen
Allergenic Extract
Approved
Approval ID
3ddfb0ed-db8a-421f-b475-a9727f413954
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 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.
Para Grass Pollen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2351
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Para Grass Pollen
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
UROCHLOA MUTICA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 3ZO9YGZ8ZJ
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT