Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209178
Company: AUROBINDO PHARMA LTD

Products on ANDA 209178

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209178

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2018	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
04/28/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/13/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/22/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
05/18/2018	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209178

IBUPROFEN

SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	074978	ACTAVIS MID ATLANTIC
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209178	AUROBINDO PHARMA LTD
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	076925	PADAGIS US
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	215311	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209204	TARO