A-A-51705A
16 July 1987
COMMERCIAL ITEM DESCRIPTION
GLYBURIDE TABLETS
The General Services Administration has authorized the use of this Commercial Item Description.
Salient Characteristics:
Shall be Glyburide Tablets.
For Strength 1, shall contain 2.5 mg of Glyburide per tablet, within the applicable assay limits.
For Strength 2, shall contain 5 mg of Glyburide per tablet, within the applicable assay limits.
Type I, tablets must be considered by the FDA to be therapeutically equivalent with Glyburide Tablets by Hoescht-Roussel Pharmaceuticals, Inc., at the same dosage and administration.
Type II, tablets must be considered by the FDA to be therapeutically equivalent with Glyburide Tablets by the Upjohn Company at the same dosage and administration.
Material used in the manufacture of the tablets shall be of a pharmaceutical grade.
Workmanship. The Tablets shall be free from defects which detract from their appearance or impair their serviceability.
Unit.
For Size 1 – Bottle (BT). One bottle containing 100 tablets, as specified, constitutes one unit.
For Size 2 – Bottle (BT). One bottle contain 500 tablets, as specified, constitutes one unit.
For Size 3 – Bottle (BT). One bottle containing 1000 tablets, as specified, constitutes one unit.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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