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FDA Approval

Thompson Seedless Grape

CompanyNelco Laboratories, Inc. (DUNS: 054980867)

Effective Date

December 9, 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Wine grape(0.1 g in 1 mL)

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 (1)

Thompson Seedless Grape

NDC Product Code

36987-1329

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 9, 2009

Ingredients

Wine grapeActive

Code: 3GOV20705GClass: ACTIBQuantity: 0.1 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

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