Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090783
Company: TEVA PHARMS USA

Products on ANDA 090783

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued	None	No	No
DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued	None	No	No
DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090783

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/2013	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090783Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2024	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/10/2024	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/10/2024	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/10/2024	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/10/2024	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/10/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/10/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/13/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.