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OsmoPrep Approval History

  • FDA approved: Yes (First approved March 16th, 2006)
  • Brand name: OsmoPrep
  • Generic name: sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous
  • Dosage form: Tablets
  • Previous name: INKP-102
  • Company: Salix Pharmaceuticals, Ltd.
  • Treatment for: Bowel Preparation

OsmoPrep (sodium biphosphate/sodium phosphate) is a bowel cleansing agent in tablet form, indicated for cleansing of the colon as a preparation for colonoscopy.

Development History and FDA Approval Process for OsmoPrep

DateArticle
Jul 26, 2005InKine Announces the Acceptance for Filing of Its New Drug Application (NDA) for Its Next Generation Purgative Product -- INKP-102
May  3, 2005InKine Announces Submission of a New Drug Application -NDA- for Its Next Generation Purgative Product - INKP-102

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