Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050678
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.

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