Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090561
Company: CIPLA
Company: CIPLA
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 |
---|---|---|---|---|---|---|---|
10/27/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090561s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/07/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
02/07/2020 | SUPPL-12 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
02/07/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
02/07/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
02/07/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
10/25/2012 | SUPPL-5 | Labeling-Package Insert |
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 |