Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050678
Company: LILLY RES LABS
Company: LILLY RES LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DYNABAC | DIRITHROMYCIN | 250MG | TABLET, DELAYED 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 |
---|---|---|---|---|---|---|---|
06/19/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050678Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/01/2002 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
08/01/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/23/2002 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50678s010ltr.pdf |
09/28/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/07/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
07/21/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/22/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/13/1998 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/19/1997 | SUPPL-3 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050678s003_dynabac_toc.cfm |
12/07/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |