9 September 1986
7 April 1986
COMMERCIAL ITEM DESCRIPTION
ISOSORBIDE DINITRATE CAPSULE,
The General Services Administration has authorized the use of this Commercial Item Description.
Shall be sustained-release Isosorbide Dinitrate Capsules.
Shall contain 40 mg of isosorbide dinitrate per capsule, within the applicable assay limits for the capsules.
For Type 1, the capsules must be considered by the FDA to be therapeutically equivalent with Isosorbide Dinitrate Capsules by Wyeth Laboratories, at the same dosage and administration schedule.
For Type 2, the capsules must be considered by the FDA to be therapeutically equivalent with Isosorbide Dinitrate Capsules by Reed and Carnrick Pharmaceuticals at the same dosage and administration schedule.
Workmanship. capsules shall be free from defects which detract from its appearance or impair their serviceability.
Unit. Bottle (BT). One bottle containing 100 capsules, as specified, constitutes one unit.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producersí own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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