MedPath
FDA Approval

Carp

December 10, 2009

HUMAN PRESCRIPTION DRUG LABEL

Smelt(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 (22)

Smelt

36987-1262

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

SmeltActive
Code: 9VVF5SCM9IClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Pike

36987-1238

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

Code: 5JKY494U4LClass: 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

White Fish

36987-1278

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: IA4C8ND0DTClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Sword Fish

36987-1266

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SwordfishActive
Code: 01695YPV36Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Trout

36987-1270

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
TroutActive
Code: 7TI7U5PF2UClass: ACTIBQuantity: 0.05 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Tuna Fish

36987-1274

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

TunaActive
Code: V2T3IHT3E2Class: 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

Scallop

36987-1254

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

ScallopActive
Code: D380C73WOUClass: 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

Flounder

36987-1210

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

FlounderActive
Code: T197LO581XClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Red Snapper

36987-1242

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: WF621S7K14Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT

Lobster

36987-1226

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 10, 2009

LobsterActive
Code: ZQ6LG2C39MClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Showing 1 to 10 of 22 products
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