A-A-51037 Amoxapine Tablets

Pages 1 - 2

A-A-51037

11 October 1985

COMMERCIAL ITEM DESCRIPTION

AMOXAPINE TABLETS

The General Services Administration has authorized the use of this commercial item description.

This commercial item description covers Amoxapine Tablets for use in the relief of symptoms of depression.

Salient characteristics:

Shall be Amoxapine tablets.

For strength 1, shall contain 50 mg of Amoxapine per tablet, within the applicable assay limits for the tablets.

For strength 2, shall contain of 100 mg of Amoxapine per tablet, within the applicable assay limits for the tablets.

Not less than 32 months of the expiration dating period shall remain at time of delivery to the Government.

Workmanship. Tablets shall be free from defects which detract from its appearance or impair its serviceability.

Unit. Bottle (BT). One bottle containing 100 tablets, as specified, constitutes one unit.

Contractor  certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ 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.

Regulatory requirements.

Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.