Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202032
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 11/17/2011 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202032Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/24/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2019 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/31/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |