Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050673
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CECLOR CD | CEFACLOR | EQ 375MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| CECLOR CD | CEFACLOR | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 06/28/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/04/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/08/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1998 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/24/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |