Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021544
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEASONALE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | 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 |
---|---|---|---|---|---|---|---|
09/05/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21544_seasonale_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21544ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-544_Seasonale.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021544s017lbl.pdf | |
01/27/2023 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021544Orig1s014,s015ltr.pdf | |
01/27/2023 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021544Orig1s014,s015ltr.pdf | |
08/09/2017 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s013ltr.pdf | |
11/05/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/31/2017 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s009s010ltr.pdf | |
03/31/2017 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s009s010ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/27/2023 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf | |
01/27/2023 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf | |
01/27/2023 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf | |
04/29/2022 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021544s017lbl.pdf | |
04/29/2022 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021544s017lbl.pdf | |
08/09/2017 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s013lbl.pdf | |
03/31/2017 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf | |
03/31/2017 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf | |
09/05/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21544_seasonale_lbl.pdf |
SEASONALE
TABLET;ORAL; 0.03MG;0.15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ICLEVIA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 206850 | AUROBINDO PHARMA LTD |
INTROVALE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 079064 | XIROMED |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 203871 | AMNEAL PHARMS |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 203164 | GLENMARK PHARMS LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 091440 | LUPIN LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 200490 | XIROMED |
QUASENSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 077101 | WATSON LABS |
SEASONALE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | Yes | AB | 021544 | TEVA BRANDED PHARM |
SETLAKIN | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 090716 | NOVAST LABS |