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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074014
Company: MISEMER

Products on ANDA 074014

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOPROFEN	KETOPROFEN	25MG	CAPSULE;ORAL	Prescription	None	No	No
KETOPROFEN	KETOPROFEN	50MG	CAPSULE;ORAL	Prescription	AB	No	No
KETOPROFEN	KETOPROFEN	75MG	CAPSULE;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074014

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1993	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
11/22/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/25/2017	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/07/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/14/1998	SUPPL-5	Labeling		Label is not available on this site.
03/28/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/28/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/19/1994	SUPPL-2	Labeling		Label is not available on this site.
08/19/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074014

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

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