Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065382
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLARITHROMYCIN | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
CLARITHROMYCIN | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
08/30/2007 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/065382s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065382s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/11/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/05/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
09/09/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
08/14/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/30/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/065382s000lbl.pdf |