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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008678
Company: EPIC PHARMA LLC

Products on NDA 008678

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISONIAZID	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ISONIAZID	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008678

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/1952	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
07/13/2016	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008678Orig1s028ltr.pdf
04/23/2007	SUPPL-26	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf
04/23/2007	SUPPL-25	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf
07/13/2000	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
02/07/2000	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
03/06/1997	SUPPL-21	Labeling		Label is not available on this site.
11/21/1995	SUPPL-20	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/01/1996	SUPPL-19	Labeling		Label is not available on this site.
08/10/1992	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/10/1992	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/23/1988	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/09/1985	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/10/1987	SUPPL-14	Labeling		Label is not available on this site.
01/04/1984	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/19/1983	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
08/19/1983	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/28/1983	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/28/1983	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/30/1980	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 008678

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/13/2016	SUPPL-28	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf

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