Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022573
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.025MG;0.8MG | TABLET, CHEWABLE;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 |
---|---|---|---|---|---|---|---|
12/22/2010 | 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/2010/022573s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022573s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573_norethindrone_ethinyl_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022573s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022573Orig1s014ltr.pdf | |
06/26/2023 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022573s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022573Orig1s012ltr.pdf | |
08/09/2017 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022573s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022573Orig1s008ltr.pdf | |
08/12/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/12/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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12/11/2013 | 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 |
---|---|---|---|---|---|
06/26/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022573s012lbl.pdf | |
04/29/2022 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022573s014lbl.pdf | |
04/29/2022 | SUPPL-14 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022573s014lbl.pdf | |
08/09/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022573s008lbl.pdf | |
12/22/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022573s000lbl.pdf |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
TABLET, CHEWABLE;ORAL; 0.025MG;0.8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KAITLIB FE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.025MG;0.8MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 203448 | LUPIN LTD |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.025MG;0.8MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 022573 | TEVA BRANDED PHARM |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.025MG;0.8MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 203371 | XIROMED |