Details for New Drug Application (NDA): 205005
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NDA 205005 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, Zydus Pharms, Actavis Mid Atlantic, Amneal Pharms, Aurobindo Pharma, Nostrum Labs Inc, Novitium Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Inventia, Omsav Pharma, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in thirty-nine NDAs. It is available from thirty-two suppliers. Additional details are available on the NITROFURANTOIN profile page.
The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 205005
| Tradename: | NITROFURANTOIN |
| Applicant: | Zydus Pharms |
| Ingredient: | nitrofurantoin, macrocrystalline |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205005
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 205005 | ANDA | Major Pharmaceuticals | 0904-7026 | 0904-7026-61 | 100 BLISTER PACK in 1 CARTON (0904-7026-61) / 1 CAPSULE in 1 BLISTER PACK |
| NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 205005 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-559 | 68382-559-01 | 100 CAPSULE in 1 BOTTLE (68382-559-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 12, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 12, 2017 | TE: | AB | RLD: | No | ||||
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