Details for New Drug Application (NDA): 091095
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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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