MedPath
FDA Approval

Cattle Epithelium

December 3, 2009

HUMAN PRESCRIPTION DRUG LABEL

Equus caballus skin(0.1 g in 1 mL)

Registrants (1)

Nelco Laboratories, Inc.

054980867

Manufacturing Establishments (1)

Nelco Laboratories, Inc.

Nelco Laboratories, Inc.

Nelco Laboratories, Inc.

054980867

Products (15)

Horse Epithelium

36987-1088

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

Code: 88VZV9HGT4Class: ACTIBQuantity: 0.1 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Silk

36987-1120

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

Code: 6LK42KUV6WClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Rabbit Epithelium

36987-1104

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

Code: Z91WAU43WCClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Mouse Epithelium

36987-1096

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: 390AN9GB09Class: ACTIBQuantity: 0.1 g in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Rat Epithelium

36987-1112

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

Code: Y69HPD48AIClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Hamster Epithelium

36987-1072

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

Code: 3K873H631WClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Cattle Epithelium

36987-1008

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

Code: 7J12CD6O9LClass: ACTIBQuantity: 0.1 g in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Goose Feathers

36987-1040

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

Code: 15XI414745Class: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Dog Epithelium

36987-1016

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Code: X2W7CLE97TClass: ACTIBQuantity: 0.1 g in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT

Hog Epithelium

36987-1080

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 3, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Code: 3EM4VW6TQNClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Showing 1 to 10 of 15 products
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