Details for New Drug Application (NDA): 209589
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NDA 209589 describes CLENPIQ, which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CLENPIQ profile page.
The generic ingredient in CLENPIQ is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
The generic ingredient in CLENPIQ is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
Summary for 209589
| Tradename: | CLENPIQ |
| Applicant: | Ferring Pharms Inc |
| Ingredient: | citric acid; magnesium oxide; sodium picosulfate |
| Patents: | 3 |
Pharmacology for NDA: 209589
Suppliers and Packaging for NDA: 209589
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLENPIQ | citric acid; magnesium oxide; sodium picosulfate | SOLUTION;ORAL | 209589 | NDA | Ferring Pharmaceuticals Inc. | 55566-6800 | 55566-6800-1 | 2 BOTTLE in 1 CARTON (55566-6800-1) / 175 mL in 1 BOTTLE (55566-6800-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 12GM/BOT;3.5GM/BOT;10MG/BOT | ||||
| Approval Date: | Nov 28, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 23, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 23, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 26, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | FOR CLEANSING THE LARGE INTESTINE AS A PREPARATION FOR COLONOSCOPY | ||||||||
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