Registrants (1)

Nelco Laboratories, Inc.

DUNS Number

054980867

Manufacturing Establishments (1)

Nelco Laboratories, Inc.

Labeler

Nelco Laboratories, Inc.

Registrant

Nelco Laboratories, Inc.

DUNS Number

054980867

Products (22)

Smelt

NDC Product Code

36987-1263

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SmeltActive

Code: 9VVF5SCM9IClass: ACTIBQuantity: 0.05 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

Pike

NDC Product Code

36987-1239

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

Northern pikeActive

Code: 5JKY494U4LClass: 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

Sardine

NDC Product Code

36987-1251

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

European pilchardActive

Code: 76780GX08DClass: ACTIBQuantity: 0.05 g in 1 mL

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Mackerel

NDC Product Code

36987-1231

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

MackerelActive

Code: CYO6K3VM7FClass: ACTIBQuantity: 0.05 g in 1 mL

PHENOLInactive

Code: 339NCG44TVClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

Scallop

NDC Product Code

36987-1255

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

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

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

White Fish

NDC Product Code

36987-1279

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

White fishActive

Code: IA4C8ND0DTClass: ACTIBQuantity: 0.05 g in 1 mL

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

Oyster

NDC Product Code

36987-1235

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

OysterActive

Code: S614XWR17VClass: ACTIBQuantity: 0.05 g in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

Trout

NDC Product Code

36987-1271

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

TroutActive

Code: 7TI7U5PF2UClass: ACTIBQuantity: 0.05 g in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Salmon

NDC Product Code

36987-1247

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

Atlantic salmonActive

Code: 7062I37LB3Class: ACTIBQuantity: 0.05 g in 1 mL

PHENOLInactive

Code: 339NCG44TVClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

Shrimp

NDC Product Code

36987-1259

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 10, 2009

Ingredients

ShrimpActive

Code: 1891LE191TClass: 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

Showing 1 to 10 of 22 products

Drug Labeling Information

HOW SUPPLIED SECTION

HOW SUPPLIED

Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml).

Sizes:

Diagnostic Scratch: 5 ml dropper application vials

Diagnostic Intradermal: 5 ml or 10 ml vials.

Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.

AI-Powered Research

Premium Access

Carp

Registrants (1)

Manufacturing Establishments (1)

Products (22)

Smelt

Pike

Sardine

Mackerel

Scallop

White Fish

Oyster

Trout

Salmon

Shrimp

Drug Labeling Information

HOW SUPPLIED SECTION

HOW SUPPLIED