Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022262
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOSEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.01MG;0.1MG,N/A TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/24/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022262lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022262s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022262_loseasonique_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022262s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262Orig1s002ltr.pdf
04/07/2015 SUPPL-1 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
08/09/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262s002lbl.pdf
08/09/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262Orig1s002ltr.pdf
10/24/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022262lbl.pdf

LOSEASONIQUE

TABLET;ORAL; 0.02MG,0.01MG;0.1MG,N/A
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.01MG;0.1MG,N/A TABLET;ORAL Prescription No AB 091674 LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.01MG;0.1MG,N/A TABLET;ORAL Prescription No AB 200407 MAYNE PHARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.01MG;0.1MG,N/A TABLET;ORAL Prescription No AB 200493 MYLAN LABS LTD
LOSEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.01MG;0.1MG,N/A TABLET;ORAL Prescription No AB 022262 TEVA BRANDED PHARM

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