Application 074967
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 50MG | No | No |
| 002 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1650 | Nitrofurantoin (macrocrystals) | nitrofurantoin (macrocrystals) | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-1308 | Nitrofurantoin | Nitrofurantoin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7655 | Nitrofurantoin | Nitrofurantoin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 55289-186 | Nitrofurantoin (macrocrystals) | nitrofurantoin (macrocrystals) | PD-Rx Pharmaceuticals, In | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22392 | ORIG | 2003-06-17 |