Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018989
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL IBUPROFEN 200MG TABLET;ORAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/18/1984 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/2017 SUPPL-88 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018989Orig1s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018989Orig1s088ltr.pdf
02/03/2017 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

04/29/2016 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

12/16/2015 SUPPL-84 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018989Orig1s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018989Orig1s084ltr.pdf
05/18/2015 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

09/01/2010 SUPPL-80 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018989s080ltr.pdf
04/26/2011 SUPPL-79 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018989Orig1s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018989s079ltr.pdf
05/19/2009 SUPPL-73 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018989s073ltr.pdf
06/11/2008 SUPPL-70 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018989s070ltr.pdf
05/01/2007 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018989s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018989s067ltr.pdf
04/04/2006 SUPPL-61 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s061ltr.pdf
04/17/2006 SUPPL-60 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s060ltr.pdf
07/16/2004 SUPPL-58 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18989s058ltr.pdf
09/26/2003 SUPPL-56 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf
04/24/2002 SUPPL-55 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf
08/02/2001 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/2001 SUPPL-53 Manufacturing (CMC)-Control Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18989s53lbl.pdf
11/15/2000 SUPPL-52 Labeling

Label is not available on this site.

10/04/1999 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

11/19/1999 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1998 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

12/19/1996 SUPPL-48 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/03/1996 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1997 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1995 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

04/04/1995 SUPPL-42 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/07/1994 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/24/1994 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1993 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1993 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/11/1994 SUPPL-37 Labeling

Label is not available on this site.

03/11/1994 SUPPL-36 Labeling

Label is not available on this site.

08/24/1990 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1993 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1991 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1989 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/14/1989 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1991 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/02/1988 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/25/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/25/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/25/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/17/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/25/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/01/1988 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/25/1988 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/05/1986 SUPPL-15 Labeling

Label is not available on this site.

12/24/1985 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/05/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/17/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/18/1984 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/23/2017 SUPPL-88 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018989Orig1s088lbl.pdf
12/16/2015 SUPPL-84 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018989Orig1s084lbl.pdf
04/26/2011 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018989Orig1s079lbl.pdf
05/01/2007 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018989s067lbl.pdf
09/26/2003 SUPPL-56 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf
04/24/2002 SUPPL-55 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf
09/07/2001 SUPPL-53 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18989s53lbl.pdf

ADVIL

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

TABLET;ORAL; 200MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 018989 PFIZER
IBU-TAB 200 IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071057 ALRA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 207095 AIPING PHARM INC
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079233 AMNEAL PHARMS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071333 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072199 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 208865 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 076460 AVEMA PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071732 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072299 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075661 DR REDDYS LA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079174 GRANULES INDIA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 202312 GRANULES INDIA LTD
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075010 LNK
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075139 LNK
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091237 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091239 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 073019 MCNEIL
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 070985 MERRO PHARM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071163 OHM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 070481 PAR PHARM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072096 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075995 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 077349 PERRIGO R AND D
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079129 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091355 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 207052 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071229 VINTAGE PHARMS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071639 VINTAGE PHARMS
IBUPROHM IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071214 OHM LABS
MOTRIN IB IBUPROFEN 200MG TABLET;ORAL Over-the-counter Yes 019012 J AND J CONSUMER INC
PROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071265 CONTRACT PHARMACAL
TAB-PROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072095 PERRIGO

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