Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078128
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZIDOVUDINE | ZIDOVUDINE | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/27/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078128ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/21/2025 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/21/2025 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2012 | SUPPL-8 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/14/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/09/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
ZIDOVUDINE
CAPSULE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RETROVIR | ZIDOVUDINE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 019655 | VIIV HLTHCARE |
| ZIDOVUDINE | ZIDOVUDINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078128 | AUROBINDO PHARMA LTD |
| ZIDOVUDINE | ZIDOVUDINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078349 | CIPLA LTD |