Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077267
Company: AUROBINDO
Company: AUROBINDO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZIDOVUDINE | ZIDOVUDINE | 300MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/19/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077267ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/10/2020 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/10/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/10/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/10/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2012 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/24/2010 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2011 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/14/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/09/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/19/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
ZIDOVUDINE
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ZIDOVUDINE | ZIDOVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077267 | AUROBINDO |
| ZIDOVUDINE | ZIDOVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 090561 | CIPLA |
| ZIDOVUDINE | ZIDOVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 090092 | HETERO LABS LTD III |