Details for New Drug Application (NDA): 091095
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NDA 091095 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, Carnegie, Nostrum Labs Inc, Novitium Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Chartwell Rx, Inventia, Micro Labs, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in forty NDAs. It is available from thirty-three 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 091095
| Tradename: | NITROFURANTOIN |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | nitrofurantoin, macrocrystalline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091095
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 091095 | ANDA | Proficient Rx LP | 71205-365 | 71205-365-14 | 14 CAPSULE in 1 BOTTLE (71205-365-14) |
| NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 091095 | ANDA | Proficient Rx LP | 71205-370 | 71205-370-10 | 10 CAPSULE in 1 BOTTLE (71205-370-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Jun 18, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Jun 18, 2015 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 18, 2015 | TE: | RLD: | No | |||||
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