Details for New Drug Application (NDA): 019071
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NDA 019071 describes UROCIT-K, which is a drug marketed by Mission Pharma and is included in one NDA. It is available from four suppliers. Additional details are available on the UROCIT-K profile page.
The generic ingredient in UROCIT-K is potassium citrate. There are two hundred and forty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the potassium citrate profile page.
The generic ingredient in UROCIT-K is potassium citrate. There are two hundred and forty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the potassium citrate profile page.
Summary for 019071
| Tradename: | UROCIT-K |
| Applicant: | Mission Pharma |
| Ingredient: | potassium citrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019071
| Mechanism of Action | Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
Medical Subject Heading (MeSH) Categories for 019071
Suppliers and Packaging for NDA: 019071
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| UROCIT-K | potassium citrate | TABLET, EXTENDED RELEASE;ORAL | 019071 | NDA | Mission Pharmacal Company | 0178-0600 | 0178-0600-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0600-01) |
| UROCIT-K | potassium citrate | TABLET, EXTENDED RELEASE;ORAL | 019071 | NDA | Mission Pharmacal Company | 0178-0610 | 0178-0610-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0610-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MEQ | ||||
| Approval Date: | Aug 30, 1985 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MEQ | ||||
| Approval Date: | Aug 31, 1992 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MEQ | ||||
| Approval Date: | Dec 30, 2009 | TE: | AB | RLD: | Yes | ||||
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