Details for New Drug Application (NDA): 217272
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The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 217272
Tradename: | NITROFURANTOIN |
Applicant: | Mankind Pharma |
Ingredient: | nitrofurantoin, macrocrystalline |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 217272
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 217272 | ANDA | American Health Packaging | 60687-839 | 60687-839-01 | 100 BLISTER PACK in 1 CARTON (60687-839-01) / 1 CAPSULE in 1 BLISTER PACK (60687-839-11) |
NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 217272 | ANDA | American Health Packaging | 60687-850 | 60687-850-01 | 100 BLISTER PACK in 1 CARTON (60687-850-01) / 1 CAPSULE in 1 BLISTER PACK (60687-850-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Mar 21, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 21, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Mar 21, 2023 | TE: | AB | RLD: | No |
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