Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 015034
Company: SHIONOGI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PONSTEL MEFENAMIC ACID 250MG 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
03/28/1967 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-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015034Orig1s044ltr.pdf
01/05/2015 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/03/2009 SUPPL-41 Labeling-Container/Carton Labels

Label is not available on this site.

03/06/2008 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015034s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015034s040ltr.pdf
01/18/2006 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/015034s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/015034s039ltr.pdf
07/31/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/04/2001 SUPPL-34 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/015034_S034_PONSTEL.pdf
09/01/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/23/1998 SUPPL-32 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/015034_S032_PONSTEL.pdf
04/05/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/04/1993 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1989 SUPPL-28 Labeling

Label is not available on this site.

06/14/1989 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/29/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/31/1983 SUPPL-21 Labeling

Label is not available on this site.

01/26/1982 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1981 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/14/1981 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/29/1981 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/17/1981 SUPPL-13 Labeling

Label is not available on this site.

02/17/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1977 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1977 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1975 SUPPL-8 Labeling

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/2016/015034s044lbl.pdf
05/09/2016 SUPPL-44 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf
05/09/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf
03/06/2008 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015034s040lbl.pdf
01/18/2006 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/015034s039lbl.pdf

PONSTEL

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEFENAMIC ACID MEFENAMIC ACID 250MG CAPSULE;ORAL Prescription No AB 091608 BELCHER PHARMS LLC
MEFENAMIC ACID MEFENAMIC ACID 250MG CAPSULE;ORAL Prescription No AB 091322 LUPIN LTD
MEFENAMIC ACID MEFENAMIC ACID 250MG CAPSULE;ORAL Prescription No AB 090562 MICRO LABS
PONSTEL MEFENAMIC ACID 250MG CAPSULE;ORAL Prescription Yes AB 015034 SHIONOGI INC

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