Short Ragweed
ALLERGENIC EXTRACT Standardized Short Ragweed
Approved
Approval ID
1482f8a2-c2c0-45a1-8e90-b427227f0b28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2019
Manufacturers
FDA
Allermed Laboratories, Inc.
DUNS: 073364531
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ambrosia artemisiifolia
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49643-315
Application NumberBLA103113
Product Classification
M
Marketing Category
C73585
G
Generic Name
Ambrosia artemisiifolia
Product Specifications
Route of AdministrationCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Effective DateSeptember 18, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM BICARBONATEInactive
Quantity: 0.125 g in 10 mL
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.25 g in 10 mL
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Quantity: 5.3 mL in 10 mL
Code: PDC6A3C0OX
Classification: IACT
AMBROSIA ARTEMISIIFOLIA POLLENActive
Quantity: 1 g in 10 mL
Code: K20Y81ACO3
Classification: ACTIB
PHENOLInactive
Quantity: 0.4 g in 10 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT