1 April 1993
24 September 1986
30 March 1987
COMMERCIAL ITEM DESCRIPTION
DIETHYLPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS
The General Services Administration has authorized the use of this Commercial Item Description.
Shall be DIethylpropion Hydrochloride Extended-Release Tablets.
Shall contain 75 mg of Diethylpropion Hydrochloride per tablet, in a timed-release formulation, when assayed by a reliable, reproducible method.
For Type I, the timed-release tablets must be considered by the FDA to be therapeutically equivalent with Diethylpropion Hydrochloride Tablets, timed-release by 3M Pharmaceuticals at the same dosage and administration schedule.
For Type II, the timed-release tablets must be considered by the FDA to be therapeutically equivalent with Diethylpropion Hydrochloride Tablets, timed-release by Marion Merrell Dow at the same dosage and administration schedule.
Each tablet shall be marked/embossed with a product identification code to identify the active ingredients(s), strength, and manufacturer. The materials used in marking/embossing the dosage forms shall be acceptable to the FDA. The actual code used for the product shall be left to the discretion of the supplier.
All ingredients entering into the manufacture of the tablets shall be of a pharmaceutical grade.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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