MedPath
FDA Approval

Fire Ant

December 11, 2009

HUMAN PRESCRIPTION DRUG LABEL

Periplaneta americana(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 (6)

Cockroach American

36987-1799

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 11, 2009

Code: 2RQ1L9N089Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

German Cockroach

36987-1841

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 11, 2009

Code: G9O67I0A8QClass: ACTIBQuantity: 0.05 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

Horse Fly

36987-1809

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 11, 2009

GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: PV7823W303Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

House Fly

36987-1791

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 11, 2009

WATERInactive
Code: 059QF0KO0RClass: IACT
Code: PV7823W303Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Mosquito

36987-1817

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 11, 2009

GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: BN2DNW66IQClass: ACTIBQuantity: 0.05 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Fire Ant

36987-1783

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 11, 2009

Code: 5O7CR4P444Class: ACTIBQuantity: 0.05 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
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