MedPath
FDA Approval

Aspergillus fumigatus

December 14, 2009

HUMAN PRESCRIPTION DRUG LABEL

Ustilago tritici(0.05 g in 1 mL)

Registrants (1)

Nelco Laboratories, Inc.

054980867

Manufacturing Establishments (1)

Nelco Laboratories, Inc.

Nelco Laboratories, Inc.

Nelco Laboratories, Inc.

054980867

Products (34)

Wheat Smut

36987-2169

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: BV82OL2IZ8Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Trichophyton mentagrophytes

36987-2133

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: 199I7J3JIVClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Saccharomyces cerevisiae

36987-2097

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: 978D8U419HClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Wheat Bunt

36987-2178

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 14, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: C7000B9PQIClass: ACTIBQuantity: 0.05 g in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Corn Smut

36987-2151

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: 4K7Z7K7SWGClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Wheat Stem Rust

36987-2187

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: O0HJ02QBWNClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Oat Smut

36987-2160

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: YIH315U1TUClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Trichoderma harzianam

36987-2124

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: CA33Q4013QClass: ACTIBQuantity: 0.05 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Fusarium compactum

36987-1980

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: V4OQR60A5PClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Curvularia inequalis

36987-1962

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: W042YAB8JCClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Showing 1 to 10 of 34 products
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