Details for New Drug Application (NDA): 207552
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NDA 207552 describes FUROSEMIDE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, Areva Pharms, Astrazeneca, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Meitheal, Saba Ilac Sanayive, Sagent, Smith And Nephew, Warner Chilcott, Watson Labs, Wockhardt, Wyeth Ayerst, Pharmobedient Cnsltg, Ani Pharms, Chartwell Rx, Epic Pharma Llc, Esjay Pharma, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Mylan, Prinston Inc, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Watson Labs Teva, and is included in sixty-five NDAs. It is available from fifty-three suppliers. Additional details are available on the FUROSEMIDE profile page.
The generic ingredient in FUROSEMIDE is furosemide. There are twenty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the furosemide profile page.
The generic ingredient in FUROSEMIDE is furosemide. There are twenty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the furosemide profile page.
Summary for 207552
| Tradename: | FUROSEMIDE |
| Applicant: | Amneal Pharms Co |
| Ingredient: | furosemide |
| Patents: | 0 |
Pharmacology for NDA: 207552
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 207552
Suppliers and Packaging for NDA: 207552
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FUROSEMIDE | furosemide | INJECTABLE;INJECTION | 207552 | ANDA | Amneal Pharmaceuticals LLC | 70121-1076 | 70121-1076-5 | 25 VIAL, GLASS in 1 CARTON (70121-1076-5) / 10 mL in 1 VIAL, GLASS (70121-1076-1) |
| FUROSEMIDE | furosemide | INJECTABLE;INJECTION | 207552 | ANDA | Amneal Pharmaceuticals LLC | 70121-1163 | 70121-1163-5 | 25 VIAL, GLASS in 1 CARTON (70121-1163-5) / 2 mL in 1 VIAL, GLASS (70121-1163-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Jul 20, 2016 | TE: | AP | RLD: | No | ||||
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