Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022262
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOSEASONIQUE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022262s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022262Orig1s006ltr.pdf | |
01/27/2023 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022262s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022262Orig1s003,s004ltr.pdf | |
01/27/2023 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022262s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022262Orig1s003,s004ltr.pdf | |
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 |
---|---|---|---|---|---|
01/27/2023 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022262s003s004lbl.pdf | |
01/27/2023 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022262s003s004lbl.pdf | |
04/29/2022 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022262s006lbl.pdf | |
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,0.1MG;0.01MG,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 AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 091674 | LUPIN LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 200493 | XIROMED |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 205131 | XIROMED |
LO SIMPESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 206852 | AUROBINDO PHARMA |
LOSEASONIQUE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 022262 | TEVA BRANDED PHARM |