Application 202051
- Type
- ANDA
- Sponsor
- SIGMAPHARM LABS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ADEFOVIR DIPIVOXIL | ADEFOVIR DIPIVOXIL | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42794-003 | ADEFOVIR DIPIVOXIL | ADEFOVIR DIPIVOXIL | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-003 | ADEFOVIR DIPIVOXIL | ADEFOVIR DIPIVOXIL | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-003 | ADEFOVIR DIPIVOXIL | ADEFOVIR DIPIVOXIL | Sigmapharm Laboratories, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 40101 | ORIG | 2013-09-19 |
| 32158 | ORIG | 2013-09-03 |