Please reference the information listed above for a description of individual tablets or capsules. This drug product has been received in one of the manufacturer or distributor packaged configurations and repackaged by Aphena Pharma — TN in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
|Count || 750mg |
|60 ||43353-771-53 |
|120 ||43353-771-70 |
|180 ||43353-771-80 |
|270 ||43353-771-92 |
|360 ||43353-771-94 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
- Morris HG, Sherman NA, McQuain C, et al: Effects of Salsalate (Non- Acetylated Salicylate) and Aspirin (ASA) on Serum Prostaglandins in Humans. Ther. Drug Monit. 7:435-438, 1985.
- April PA, Curran NJ, Ekohlm BP, et al: Multicenter Comparative Study of Salsalate (SSA) vs Aspirin (ASA) in Rheumatoid Arthritis (RA), Arthritis Rheumatism 30 (4 supplement):S93, 1987.
- Deodhar SD, McLeod MM, Dick WC, et al: A Short-Term Comparative Trial of Salsalate and Indomethacin in Rheumatoid Arthritis. Curr. Med. Res. Opin., 5:185-188,1977.
- Estes D, Kaplan K: Lack of Platelet Effect With the Aspirin Analog, Salsalate, Arthritis and Rheumatism, 23:1303-1307, 1980.
- Dick C, Dick PH, Nuki G, et al: Effect of Anti-inflammatory Drug Therapy on Clearance of 133Xe from Knee Joints of Patients with Rheumatoid Arthritis. British Med. J. 3:278-280, 1969.
- Dick WC, Grayson MF, Woodburn A, et al: Indices of Inflammatory Activity. Ann. of the Rheum. Dis. 29:643-648, 1970.
- Cohen A:Fecal Blood Loss and Plasma Salicylate Study of Salicylsalicylic Acid and Aspirin. J. Clin. Pharmacol. 19:242-247, 1979.
- Chudwin DS, Strub M. Golden HE, et al: Sensitivity to Non-Acetylated Salicylates in a Patient with Asthma, Nasal Polyps, and Rheumatoid Arthritis. Annals of Allergy 57:133-134, 1986.
- Spector SL, Wangaard CH, Farr RS: Aspirin and Concomitant Idiosyncrasies in Adult Asthmatic Patients. J. Allergy Clin. Immunol 64:500-506, 1979.
- Stevenson DD, Schrank PJ, Hougham AJ, et al: Salsalate Cross Sensitivity in Aspirin-Sensitive Asthmatics. J. Allergy Clin. Immunol 81:181, 1988.
1212 Cranbury S River Road
Cranbury, NJ 08512
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Cookeville, TN 38506
PRINCIPAL DISPLAY PANEL
| SALSALATE |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:43353-771(NDC:51862-142) |
|Route of Administration ||ORAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|SALSALATE (SALSALATE) ||SALSALATE ||750 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| COLLOIDAL SILICON DIOXIDE || |
| CROSCARMELLOSE SODIUM || |
| D&C YELLOW NO. 10 || |
| HYPROMELLOSES || |
| MICROCRYSTALLINE WAX || |
| MINERAL OIL || |
| POLYETHYLENE GLYCOL || |
| STEARIC ACID || |
| TALC || |
| TITANIUM DIOXIDE || |
|Product Characteristics |
|Color ||YELLOW (YELLOW) ||Score ||no score |
|Shape ||CAPSULE (Capsule) ||Size ||17mm |
|Flavor || ||Imprint Code ||SL;750 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:43353-771-53 ||60 TABLET (60 TABLET) in 1 BOTTLE, PLASTIC ||None |
| 2 ||NDC:43353-771-70 ||120 TABLET (120 TABLET) in 1 BOTTLE, PLASTIC ||None |
| 3 ||NDC:43353-771-80 ||180 TABLET (180 TABLET) in 1 BOTTLE, PLASTIC ||None |
| 4 ||NDC:43353-771-92 ||270 TABLET (270 TABLET) in 1 BOTTLE, PLASTIC ||None |
| 5 ||NDC:43353-771-94 ||360 TABLET (360 TABLET) in 1 BOTTLE, PLASTIC ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|Unapproved drug other || ||05/22/2011 || |
|Labeler — Aphena Pharma Solutions — Tennessee, Inc.
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Aphena Pharma Solutions — Tennessee, Inc. || ||128385585 ||Repack (43353-771) |
Revised: 03/2012 Aphena Pharma Solutions — Tennessee, Inc.
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