Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091608
Company: BELCHER

Products on ANDA 091608

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 091608

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/2014	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
10/29/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091608

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