Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073516
Company: TEVA

Products on ANDA 073516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOPROFEN	KETOPROFEN	50MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073516

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1992	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-28	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/29/2006	SUPPL-23	Labeling		Label is not available on this site.
03/08/2006	SUPPL-21	Labeling		Label is not available on this site.
10/24/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-15	Manufacturing (CMC)-Facility		Label is not available on this site.
01/14/2000	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
03/26/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/14/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/10/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/13/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/17/1998	SUPPL-9	Labeling		Label is not available on this site.
03/14/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/14/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/31/1995	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/16/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/06/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/15/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073516

KETOPROFEN

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOPROFEN	KETOPROFEN	50MG	CAPSULE;ORAL	Prescription	No	AB	074014	MISEMER
KETOPROFEN	KETOPROFEN	50MG	CAPSULE;ORAL	Prescription	No	AB	073516	TEVA