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OsmoPrep FDA Approval History

FDA Approved: Yes (First approved March 16, 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 Timeline 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

Further information

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