Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022574
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SAFYRAL DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG TABLET;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
12/16/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022574s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022574s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022574_safyral_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022574Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022574s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022574Orig1s009ltr.pdf
06/01/2015 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022574s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf
04/10/2012 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022574Orig1s004.pdf
02/13/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022574s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022574Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022574s009lbl.pdf
06/01/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022574s006lbl.pdf
04/10/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s004lbl.pdf
02/13/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s001lbl.pdf
12/16/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022574s000lbl.pdf

SAFYRAL

TABLET;ORAL; 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription No AB 203594 WATSON LABS INC
SAFYRAL DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription Yes AB 022574 BAYER HLTHCARE
TYDEMY DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription No AB 205948 LUPIN LTD

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