Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065016
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
| AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/08/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65016ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/30/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/31/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/04/2006 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/29/2005 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/23/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/10/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/22/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/29/2000 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |