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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021472
Company: BIONPHARMA

Products on NDA 021472

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIDOL LIQUID GELS	IBUPROFEN	200MG	CAPSULE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021472

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21472ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-472_Ibuprofen.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2021	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021472Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021472Orig1s015ltr.pdf
03/16/2017	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021472Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021472Orig1s014ltr.pdf
04/28/2010	SUPPL-13	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021472s013ltr.pdf
04/15/2009	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021472s012ltr.pdf
02/19/2009	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021472s011ltr.pdf
12/18/2006	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021472s007ltr.pdf
12/21/2005	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021472s006ltr.pdf
03/13/2006	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021472s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021472s005ltr.pdf
01/22/2004	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21472slr001_ibuprofen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21472slr001ltr.pdf

Labels for NDA 021472

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2021	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021472Orig1s015lbl.pdf
03/16/2017	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021472Orig1s014lbl.pdf
03/16/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021472Orig1s014lbl.pdf
03/13/2006	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021472s005lbl.pdf
01/22/2004	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21472slr001_ibuprofen_lbl.pdf

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

MIDOL LIQUID GELS

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

CAPSULE;ORAL; 200MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MIDOL LIQUID GELS	IBUPROFEN	200MG	CAPSULE;ORAL	Over-the-counter	Yes	021472	BIONPHARMA

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