Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018147
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FELDENE PIROXICAM 10MG CAPSULE;ORAL Prescription AB Yes No
FELDENE PIROXICAM 20MG CAPSULE;ORAL Prescription AB 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
04/06/1982 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/09/2016 SUPPL-44 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018147Orig1s044ltr.pdf
02/27/2015 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf
06/19/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/27/2015 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf
02/27/2015 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf
02/27/2015 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf
02/27/2015 SUPPL-33 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf
08/13/2010 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018147s032ltr.pdf
07/05/2007 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018147s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018147s030_ltr.pdf
01/24/2006 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018147s029ltr.pdf
01/08/2003 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18147slr028ltr.pdf
03/09/2000 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1998 SUPPL-26 Labeling

Label is not available on this site.

09/14/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/25/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/14/1998 SUPPL-23 Labeling

Label is not available on this site.

05/16/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/14/1998 SUPPL-21 Labeling

Label is not available on this site.

08/24/1988 SUPPL-20 Labeling

Label is not available on this site.

07/23/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/14/1998 SUPPL-18 Labeling

Label is not available on this site.

04/23/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/18/1985 SUPPL-15 Labeling

Label is not available on this site.

12/10/1984 SUPPL-12 Labeling

Label is not available on this site.

11/19/1984 SUPPL-11 Labeling

Label is not available on this site.

07/17/1984 SUPPL-10 Labeling

Label is not available on this site.

09/10/1984 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/17/1984 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/21/1983 SUPPL-7 Labeling

Label is not available on this site.

05/03/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/18/1983 SUPPL-4 Labeling

Label is not available on this site.

02/22/1983 SUPPL-3 Labeling

Label is not available on this site.

01/13/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf
05/09/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf
05/09/2016 SUPPL-44 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf
02/27/2015 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
02/27/2015 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
02/27/2015 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
02/27/2015 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
02/27/2015 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
08/13/2010 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf
07/05/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018147s030lbl.pdf
01/24/2006 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf

FELDENE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELDENE PIROXICAM 10MG CAPSULE;ORAL Prescription Yes AB 018147 PFIZER
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 207938 FLAMINGO PHARMS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 209256 HIKMA PHARMS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 074116 MYLAN IRELAND LTD
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 206136 PII
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 074131 TEVA
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 208340 UNICHEM LABS LTD

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELDENE PIROXICAM 20MG CAPSULE;ORAL Prescription Yes AB 018147 PFIZER
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 207938 FLAMINGO PHARMS
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 209256 HIKMA PHARMS
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 074118 MYLAN IRELAND LTD
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 206136 PII
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 074131 TEVA
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 208340 UNICHEM LABS LTD

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