Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090092
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZIDOVUDINE | ZIDOVUDINE | 300MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/25/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090092s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/10/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/10/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/10/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2009 | SUPPL-1 | 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 |
| ZIDOVUDINE | ZIDOVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 078922 | MYLAN PHARMS INC |