flammatory drugs or systemic corticosteroids may be continued when Depen is initiated. After improvement commences, analgesic and anti-inflammatory drugs may be slowly discontinued as symptoms permit. Steroid withdrawal must be done gradually, and many months of Depen treatment may be required before steroids can be completely eliminated.
Dosage Frequency - Based on clinical experience, dosages up to 500 mg/day can be given as a single daily dose. Dosages in excess of 500 mg/day should be administered in divided doses.
How is Depen Supplied
Depen® (penicillamine tablets, USP) Titratable Tablets: 250 mg scored, oval, white tablets coded with 37-4401; available in bottles of 100 (NDC 003-4401-01).
Storage: Store at controlled room temperature 20°–25°C (68°–77°F). Protect from moisture.
Dispense in a tight container.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237
For:
Meda Pharmaceuticals
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120
©2009 Meda Pharmaceuticals Inc.
70018452 Rev. 4/09
Package Label - Principal Display Panel – 100 Tablet Bottle, Depen Titratable Tablets
NDC 0037-4401-01
100 Tablets
Depen®
(penicillamine
tablets, USP)
Titratable Tablets
250 mg
Rx Only
Meda
Pharmaceuticals®
Usual Dosage: See attached package circular for full
prescribing information.
Store at controlled room temperature 20°-25°C
(68°-77°F). Protect from moisture. Dispense in a
tight container.
Manufactured by: Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237
For: Meda Pharmaceuticals
Meda Pharmaceuticals Inc.
Somerset, NJ 08873-4120
©2009 Meda Pharmaceuticals Inc.
70018451
Depen
penicillamine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-4401
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLAMINE (PENICILLAMINE) PENICILLAMINE 250 mg
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 14mm
Flavor Imprint Code 37;4401
Contains
Packaging
Item Code Package Description
1 NDC:0037-4401-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019854 11/30/1978
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