Application 201722
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 25MG | No | No |
| 002 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 50MG | No | No |
| 003 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-5693 | Nitrofurantion | Nitrofurantion | A-S Medication Solutions | ANDA | Current |
| 50090-5693 | Nitrofurantion | Nitrofurantion | A-S Medication Solutions | ANDA | Current |
| 55700-893 | Nitrofurantion | Nitrofurantion | Quality Care Products, LLC | ANDA | Current |
| 55700-893 | Nitrofurantion | Nitrofurantion | Quality Care Products, LLC | ANDA | Current |
| 57664-231 | Nitrofurantion | Nitrofurantion | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-232 | Nitrofurantion | Nitrofurantion | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-233 | Nitrofurantion | Nitrofurantion | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 60687-472 | Nitrofurantoin | Nitrofurantoin | American Health Packaging | ANDA | Current |
| 60687-472 | Nitrofurantoin | Nitrofurantoin | American Health Packaging | ANDA | Current |
| 60687-483 | Nitrofurantoin | Nitrofurantoin | American Health Packaging | ANDA | Current |
| 60687-483 | Nitrofurantoin | Nitrofurantoin | American Health Packaging | ANDA | Current |
| 61919-024 | NITROFURANTION | NITROFURANTION | DIRECT RX | ANDA | Current |
| 61919-024 | NITROFURANTION | NITROFURANTION | DIRECT RX | ANDA | Current |
| 68001-384 | Nitrofurantion | Nitrofurantion | BluePoint Labortories | ANDA | Current |
| 68001-385 | Nitrofurantion | Nitrofurantion | BluePoint Labortories | ANDA | Current |
| 68001-386 | Nitrofurantion | Nitrofurantion | BluePoint Labortories | ANDA | Current |
| 68071-2363 | Nitrofurantion | Nitrofurantion | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2647 | Nitrofurantion | Nitrofurantion | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3134 | Nitrofurantion | Nitrofurantion | NuCare Pharmaceuticals Industries, Inc. | ANDA | Current |
| 70518-3041 | Nitrofurantion | Nitrofurantion | REMEDYREPACK INC. | ANDA | Current |
| 70934-413 | Nitrofurantion | Nitrofurantion | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-413 | Nitrofurantion | Nitrofurantion | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71335-0024 | Nitrofurantion | Nitrofurantion | Bryant Ranch Prepack | ANDA | Current |
| 71335-0793 | Nitrofurantion | Nitrofurantion | Bryant Ranch Prepack | ANDA | Current |
| 71335-0793 | Nitrofurantion | Nitrofurantion | Bryant Ranch Prepack | ANDA | Current |
| 71335-0793 | Nitrofurantion | Nitrofurantion | Bryant Ranch Prepack | ANDA | Current |