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Application 077267
- Type
- ANDA
- Sponsor
- AUROBINDO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZIDOVUDINE | ZIDOVUDINE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 21695-369 | Zidovudine | ZIDOVUDINE | Rebel Distributors Corp | ANDA | Current |
| 52343-045 | Zidovudine | Zidovudine | ACETRIS HEALTH, LLC | ANDA | Current |
| 53808-0812 | Zidovudine | ZIDOVUDINE | DOH CENTRAL PHARMACY | ANDA | Current |
| 57237-241 | Zidovudine | Zidovudine | Citron Pharma LLC | ANDA | Current |
| 65862-024 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-024 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-024 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-024 | Zidovudine | Zidovudine | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31212 | ORIG | 2005-09-22 |