Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081113
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERGOLOID MESYLATES | ERGOLOID MESYLATES | 1MG | TABLET;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1991 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/09/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/06/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/10/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |