Details for New Drug Application (NDA): 021314
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NDA 021314 describes IDKIT:HP, which is a drug marketed by Meridian Bioscience and is included in one NDA. It is available from one supplier. Additional details are available on the IDKIT:HP profile page.
The generic ingredient in IDKIT:HP is citric acid; urea c-13. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; urea c-13 profile page.
The generic ingredient in IDKIT:HP is citric acid; urea c-13. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; urea c-13 profile page.
Summary for 021314
| Tradename: | IDKIT:HP |
| Applicant: | Meridian Bioscience |
| Ingredient: | citric acid; urea c-13 |
| Patents: | 0 |
Pharmacology for NDA: 021314
| Mechanism of Action | Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 021314
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IDKIT:HP | citric acid; urea c-13 | FOR SOLUTION, TABLET, FOR SOLUTION;ORAL | 021314 | NDA | Meridian Bioscience Israel Ltd | 50402-100 | 50402-100-13 | 25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG |
| IDKIT:HP | citric acid; urea c-13 | FOR SOLUTION, TABLET, FOR SOLUTION;ORAL | 021314 | NDA | Meridian Bioscience Israel Ltd | 50402-100 | 50402-100-14 | 5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION, TABLET, FOR SOLUTION;ORAL | Strength | 4GM;75MG | ||||
| Approval Date: | Dec 17, 2002 | TE: | RLD: | Yes | |||||
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