Details for New Drug Application (NDA): 203546
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NDA 203546 describes POTASSIUM CITRATE, which is a drug marketed by Ut Sw Medctr, Ani Pharms, Ascent Pharms Inc, Bionpharma, Hibrow Hlthcare, Rising, Strides Pharma, Teva Pharms Usa Inc, Torrent, and Zydus Pharms, and is included in ten NDAs. It is available from fourteen suppliers. Additional details are available on the POTASSIUM CITRATE profile page.
The generic ingredient in POTASSIUM CITRATE 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 POTASSIUM CITRATE 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 203546
| Tradename: | POTASSIUM CITRATE |
| Applicant: | Zydus Pharms |
| Ingredient: | potassium citrate |
| Patents: | 0 |
Pharmacology for NDA: 203546
| Mechanism of Action | Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
Medical Subject Heading (MeSH) Categories for 203546
Suppliers and Packaging for NDA: 203546
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CITRATE | potassium citrate | TABLET, EXTENDED RELEASE;ORAL | 203546 | ANDA | Golden State Medical Supply, Inc. | 51407-449 | 51407-449-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-449-01) |
| POTASSIUM CITRATE | potassium citrate | TABLET, EXTENDED RELEASE;ORAL | 203546 | ANDA | Golden State Medical Supply, Inc. | 51407-450 | 51407-450-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-450-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MEQ | ||||
| Approval Date: | Aug 6, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MEQ | ||||
| Approval Date: | Aug 6, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MEQ | ||||
| Approval Date: | Aug 6, 2014 | TE: | AB | RLD: | No | ||||
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