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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205647
Company: PAI HOLDINGS PHARM

Products on ANDA 205647

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

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Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205647

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
11/03/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

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Supplements

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Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
11/21/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/22/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

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