Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214475
Company: RISING

Products on ANDA 214475

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214475

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214475Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214475

FENOPROFEN CALCIUM

CAPSULE;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE;ORAL	Prescription	No	AB	215548	MISEMER
FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE;ORAL	Prescription	No	AB	214475	RISING