Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 016848
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANADROL-50 OXYMETHOLONE 50MG TABLET;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
01/18/1972 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
02/06/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/25/2004 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16848s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16848s021ltr.pdf
11/17/2003 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16848slr020ltr.pdf
02/06/2002 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/14/1997 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1994 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1993 SUPPL-16 Labeling

Label is not available on this site.

02/18/1992 SUPPL-15 Labeling

Label is not available on this site.

08/24/1992 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1993 SUPPL-13 Labeling

Label is not available on this site.

08/14/1991 SUPPL-12 Labeling

Label is not available on this site.

01/26/1990 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1986 SUPPL-10 Labeling

Label is not available on this site.

01/18/1983 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1980 SUPPL-6 Labeling

Label is not available on this site.

06/15/1976 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/10/1975 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/25/2004 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16848s021lbl.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