Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 075315
Company: UPSHER SMITH LABS

Other Important Information from FDA

Products on ANDA 075315

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET;ORAL	Discontinued	None	No	No
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075315

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/1998	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75315ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075315_amiodarone_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2019	SUPPL-47	Labeling-Package Insert		Label is not available on this site.
11/21/2019	SUPPL-46	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/21/2019	SUPPL-45	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/24/2015	SUPPL-44	Labeling-Package Insert		Label is not available on this site.
07/24/2015	SUPPL-42	Labeling-Package Insert		Label is not available on this site.
07/24/2015	SUPPL-41	Labeling-Package Insert		Label is not available on this site.
07/24/2015	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
07/24/2015	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
06/28/2013	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
05/31/2013	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
05/31/2013	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
06/29/2010	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/17/2008	SUPPL-25	Labeling		Label is not available on this site.
11/30/2006	SUPPL-22	Labeling		Label is not available on this site.
04/10/2006	SUPPL-21	Labeling		Label is not available on this site.
03/28/2006	SUPPL-20	Labeling		Label is not available on this site.
03/28/2006	SUPPL-18	Labeling		Label is not available on this site.
02/18/2005	SUPPL-17	Labeling		Label is not available on this site.
10/29/2004	SUPPL-16	Labeling		Label is not available on this site.
10/04/2004	SUPPL-15	Labeling		Label is not available on this site.
06/24/2004	SUPPL-12	Labeling		Label is not available on this site.
08/26/2002	SUPPL-9	Labeling		Label is not available on this site.
05/08/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
05/08/2002	SUPPL-7	Manufacturing (CMC)-Facility	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.pdf
01/11/2000	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.pdf
06/30/2000	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf
06/30/2000	SUPPL-4	Manufacturing (CMC)-New Strength	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf
02/02/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
07/21/1999	SUPPL-1	Labeling		Label is not available on this site.