Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210602
Company: APTAPHARMA INC

Products on ANDA 210602

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 210602

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2018	ORIG-1	Approval		STANDARD		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	J AND J CONSUMER INC
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	210602	APTAPHARMA INC
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	209207	TARO