Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021840
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEASONIQUE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | 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 |
---|---|---|---|---|---|---|---|
05/25/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021840lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021840s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021840s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021840s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021840Orig1s015ltr.pdf | |
01/27/2023 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021840Orig1s012,s013ltr.pdf | |
01/27/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021840Orig1s012,s013ltr.pdf | |
08/09/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021840s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021840Orig1s011ltr.pdf | |
09/22/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/29/2010 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021840s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021840s008ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/27/2023 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf | |
01/27/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf | |
01/27/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf | |
04/29/2022 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021840s015lbl.pdf | |
08/09/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021840s011lbl.pdf | |
07/29/2010 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021840s008lbl.pdf | |
05/25/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021840lbl.pdf |
SEASONIQUE
TABLET;ORAL; 0.03MG,0.01MG;0.15MG,N/A
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASHLYNA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 203163 | GLENMARK PHARMS LTD |
DAYSEE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 091467 | LUPIN LTD |
JAIMIESS | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 203770 | XIROMED |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 203872 | AMNEAL PHARMS |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 078834 | DR REDDYS LABS SA |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 200492 | XIROMED |
SEASONIQUE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | Yes | AB | 021840 | TEVA BRANDED PHARM |
SIMPESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 206851 | AUROBINDO PHARMA |