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FDA Approval

Cotton Linters

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

FDA Approval Summary

Company
Antigen Laboratories, Inc.
DUNS: 030705628
Effective Date
November 13, 2009
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cotton(0.05 g in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Antigen Laboratories, Inc.

030705628

Manufacturing Establishments1

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

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

030705628

Products9

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

Cotton Linters

Product Details

NDC Product Code
49288-0154
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
CottonActive
Code: 70LDW53ROOClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL

Kapok

Product Details

NDC Product Code
49288-0285
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
Ceiba pentandra fiberActive
Code: 758Z9H9WV9Class: ACTIBQuantity: 0.05 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Leaf Tobacco

Product Details

NDC Product Code
49288-0581
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
Tobacco leafActive
Code: 6YR2608RSUClass: ACTIBQuantity: 0.1 g in 1 mL

Leaf Tobacco

Product Details

NDC Product Code
49288-0582
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Tobacco leafActive
Code: 6YR2608RSUClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL

Leaf Tobacco

Product Details

NDC Product Code
49288-0583
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
Tobacco leafActive
Code: 6YR2608RSUClass: ACTIBQuantity: 0.02 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL

Orris Root

Product Details

NDC Product Code
49288-0343
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
OrrisActive
Code: M30XO5X4XDClass: ACTIBQuantity: 0.1 g in 1 mL

Orris Root

Product Details

NDC Product Code
49288-0344
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
OrrisActive
Code: M30XO5X4XDClass: ACTIBQuantity: 0.05 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL

Pyrethrum

Product Details

NDC Product Code
49288-0403
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
Tanacetum cinerariifolium flowerActive
Code: CGF76TP7X6Class: ACTIBQuantity: 0.05 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL

Jute

Product Details

NDC Product Code
49288-0272
Application Number
BLA102223
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS, INTRADERMAL
Effective Date
November 13, 2009
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
Corcorus capsularis fiberActive
Code: TVA75O7S63Class: ACTIBQuantity: 0.05 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
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