Details for New Drug Application (NDA): 206813
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NDA 206813 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 thirteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the potassium citrate profile page.
Summary for 206813
| Tradename: | POTASSIUM CITRATE |
| Applicant: | Strides Pharma |
| Ingredient: | potassium citrate |
| Patents: | 0 |
Pharmacology for NDA: 206813
| Mechanism of Action | Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
Medical Subject Heading (MeSH) Categories for 206813
Suppliers and Packaging for NDA: 206813
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CITRATE | potassium citrate | TABLET, EXTENDED RELEASE;ORAL | 206813 | ANDA | Strides Pharma Inc. | 42543-406 | 42543-406-01 | 100 TABLET in 1 BOTTLE (42543-406-01) |
| POTASSIUM CITRATE | potassium citrate | TABLET, EXTENDED RELEASE;ORAL | 206813 | ANDA | Strides Pharma Inc. | 42543-407 | 42543-407-01 | 100 TABLET in 1 BOTTLE (42543-407-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MEQ | ||||
| Approval Date: | Sep 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MEQ | ||||
| Approval Date: | Sep 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MEQ | ||||
| Approval Date: | Sep 11, 2017 | TE: | AB | RLD: | No | ||||
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