Details for New Drug Application (NDA): 016620
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NDA 016620 describes MACRODANTIN, which is a drug marketed by Almatica and is included in one NDA. It is available from seven suppliers. Additional details are available on the MACRODANTIN profile page.
The generic ingredient in MACRODANTIN is nitrofurantoin, macrocrystalline. Twenty-eight suppliers are listed for this compound. Additional details are available on the nitrofurantoin, macrocrystalline profile page.
The generic ingredient in MACRODANTIN is nitrofurantoin, macrocrystalline. Twenty-eight suppliers are listed for this compound. Additional details are available on the nitrofurantoin, macrocrystalline profile page.
Summary for 016620
| Tradename: | MACRODANTIN |
| Applicant: | Almatica |
| Ingredient: | nitrofurantoin, macrocrystalline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 016620
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MACRODANTIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 016620 | NDA | Alvogen Inc. | 47781-306 | 47781-306-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (47781-306-01) |
| MACRODANTIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 016620 | NDA | Alvogen Inc. | 47781-307 | 47781-307-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (47781-307-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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