Application 077025
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 100MG | No | No |
| 002 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 25MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1700 | Nitrofurantoin (macrocrystals) | nitrofurantoin (macrocrystals) | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 35356-681 | Nitrofurantoin (macrocrystals) | nitrofurantoin (macrocrystals) | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |