Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 012911
Company: HRA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOPIRONE METYRAPONE 250MG TABLET;ORAL Discontinued None No No
METOPIRONE METYRAPONE 250MG CAPSULE;ORAL Prescription 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
12/04/1961 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/20/2020 SUPPL-36 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012911s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/012911Orig1s036ltr.pdf
10/22/2018 SUPPL-35 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012911s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012911Orig1s035ltr.pdf
08/14/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/05/2013 SUPPL-33 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012911Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012911Orig1s033ltr.pdf
09/20/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/28/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/19/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/04/2010 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012911s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012911s026ltr.pdf
05/07/2004 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12911slr023ltr.pdf
04/21/1999 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/27/1996 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/09/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1992 SUPPL-15 Labeling

Label is not available on this site.

03/26/1992 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1986 SUPPL-13 Labeling

Label is not available on this site.

01/10/1986 SUPPL-12 Labeling

Label is not available on this site.

08/29/1984 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1983 SUPPL-10 Labeling

Label is not available on this site.

02/03/1978 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/02/1976 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
02/20/2020 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012911s036lbl.pdf
02/20/2020 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012911s036lbl.pdf
10/22/2018 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012911s035lbl.pdf
10/22/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012911s035lbl.pdf
09/05/2013 SUPPL-33 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012911Orig1s033lbl.pdf
11/04/2010 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012911s026lbl.pdf

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