Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021472
Company: BIONPHARMA INC
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English