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Application 077268
- Type
- ANDA
- Sponsor
- AUROBINDO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZIDOVUDINE | ZIDOVUDINE | SYRUP;ORAL | 50MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-048 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-048 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-048 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-048 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-048 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9027 | ORIG | 2005-09-22 |
| 31213 | ORIG | 2005-09-14 |