A-A-53727A
The tablets shall assay to contain the labeled amount of Warfarin Sodium, USP within the applicable assay limits for the tablets.
The tablets must be considered by the FDA to be therapeutically equivalent to Coumadin Tablets by Dupont Pharmaceuticals at the same dosage and administration schedule.
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 of the supplier.
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 containing 1000 tablets, as specified, constitutes one unit.
For Size 3 – Package (PG). One package containing 100 unit dose tablets, as specified, constitutes one unit.
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