[METRIC]
A-A-53363A
22 April 1994
SUPERSEDING
A-A-0053363 (DM)
14 February 1988
COMMERCIAL ITEM DESCRIPTION
NIFEDIPINE CAPSULES, USP
The General Services Administration has authorized the use of this Commercial Item Description.
Salient characteristics.
Shall be Nifedipine Capsules, USP.
Shall be in accordance with the requirements of the USP.
For Strength 1, shall contain 10 mg of Nifedipine per capsule, within the capsule within the applicable assay limits.
For Strength 2, shall contain 20 mg of Nifedipine per capsule, within the capsule within the applicable assay limits.
All ingredients shall be of a pharmaceutical grade.
Workmanship. The capsules shall be free from defects which detract from their appearance or impair their serviceability.
Each capsule shall be marked/embossed with a product identification code to identify the active ingredient(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.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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