Application 078128
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZIDOVUDINE | ZIDOVUDINE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52343-044 | Zidovudine | Zidovudine | ACETRIS HEALTH, LLC | ANDA | Current |
| 65862-107 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-107 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-107 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-107 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9121 | ORIG | 2006-04-05 |