MedPath
FDA Approval

Aspergillus fumigatus

December 14, 2009

HUMAN PRESCRIPTION DRUG LABEL

Tilletia caries(10000 [PNU] 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 Bunt

36987-2172

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 14, 2009

Code: C7000B9PQIClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Fusarium compactum

36987-1974

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: V4OQR60A5PClass: ACTIBQuantity: 10000 [PNU] in 1 mL

Wheat Stem Rust

36987-2181

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: O0HJ02QBWNClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Phoma glomerata

36987-2055

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 14, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Code: UPX000VMIFClass: ACTIBQuantity: 10000 [PNU] in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Curvularia inequalis

36987-1956

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: W042YAB8JCClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Stemphylium sarciniforms

36987-2109

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 14, 2009

Code: XQ14H1462MClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Wheat Smut

36987-2163

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: BV82OL2IZ8Class: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Saccharomyces cerevisiae

36987-2091

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: 978D8U419HClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Rhodotorula mucilaginosa

36987-2082

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Code: 62TY3X4N9ZClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Penicilium chrysogenum

36987-2037

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 14, 2009

Code: 3Y1PE1GCIGClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Showing 1 to 10 of 34 products
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