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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209207
Company: SUN PHARMA CANADA

Products on ANDA 209207

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209207

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/24/2018	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

IBUPROFEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUSPENSION;ORAL; 100MG/5ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S ADVIL	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	020589	HALEON US HOLDINGS
CHILDREN'S ADVIL-FLAVORED	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	020589	HALEON US HOLDINGS
CHILDREN'S IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	074937	PERRIGO
CHILDREN'S MOTRIN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	Yes	020516	KENVUE BRANDS
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	210602	ANNORA PHARMA
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	209179	AUROBINDO PHARMA LTD
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	210149	GUARDIAN DRUG
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	074916	P AND L
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	214789	PAI HOLDINGS PHARM
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	220239	RUBICON RESEARCH
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	211666	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	209207	SUN PHARMA CANADA

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