Details for New Drug Application (NDA): 076368
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NDA 076368 describes POTASSIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Endo Operations, Glenmark Pharms Ltd, Granules, Lupin Ltd, Nesher Pharms, Novel Labs Inc, Padagis Us, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Amneal, Belcher, Epic Pharma Llc, Genus, Novitium Pharma, Rubicon, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Nexus Pharms, Pharma Serve Ny, Watson Labs, Anda Repository, Apotex, Genus Lifesciences, Pharm Assoc, Sciegen Pharms Inc, Wes Pharma Inc, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Macleods Pharms Ltd, Mylan, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, Icu Medical Inc, and Nexus, and is included in one hundred and thirty-one NDAs. It is available from seventy-eight suppliers. Additional details are available on the POTASSIUM CHLORIDE profile page.
The generic ingredient in POTASSIUM CHLORIDE is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.
The generic ingredient in POTASSIUM CHLORIDE is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.
Summary for 076368
| Tradename: | POTASSIUM CHLORIDE |
| Applicant: | Adare Pharms Inc |
| Ingredient: | potassium chloride |
| Patents: | 0 |
Pharmacology for NDA: 076368
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 076368
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE | potassium chloride | TABLET, EXTENDED RELEASE;ORAL | 076368 | ANDA | American Health Packaging | 60687-632 | 60687-632-01 | 100 BLISTER PACK in 1 CARTON (60687-632-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-632-11) |
| POTASSIUM CHLORIDE | potassium chloride | TABLET, EXTENDED RELEASE;ORAL | 076368 | ANDA | Proficient Rx LP | 63187-668 | 63187-668-03 | 3 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-668-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 20MEQ | ||||
| Approval Date: | Aug 18, 2004 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MEQ | ||||
| Approval Date: | Jun 5, 2019 | TE: | AB1 | RLD: | No | ||||
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