Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090562
Company: MICRO LABS

Products on ANDA 090562

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEFENAMIC ACID	MEFENAMIC ACID	250MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090562

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2010	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
09/06/2022	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/30/2019	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
10/30/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/30/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090562

MEFENAMIC ACID

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEFENAMIC ACID	MEFENAMIC ACID	250MG	CAPSULE;ORAL	Prescription	No	AB	091608	BELCHER
MEFENAMIC ACID	MEFENAMIC ACID	250MG	CAPSULE;ORAL	Prescription	No	AB	091322	LUPIN LTD
MEFENAMIC ACID	MEFENAMIC ACID	250MG	CAPSULE;ORAL	Prescription	No	AB	090562	MICRO LABS
PONSTEL	MEFENAMIC ACID	250MG	CAPSULE;ORAL	Prescription	Yes	AB	015034	AVION PHARMS