Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050678
Company: LILLY RES LABS

Products on NDA 050678

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050678

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.