ALESSE از شرکت CADENCE HEALTH

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALESSE از شرکت CADENCE HEALTH

New Drug Application (NDA): 020683

Company: CADENCE HEALTH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-21 Discontinued

None

Yes No
ALESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-28 Discontinued

None

Yes 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
03/27/1997 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020683_alesse_toc.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2018 SUPPL-12 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020683s012lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020683Orig1s012ltr.pdf

08/09/2017 SUPPL-11 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020683s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020683Orig1s011ltr.pdf

01/31/2008 SUPPL-7 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s007ltr.pdf

01/31/2008 SUPPL-6 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s006ltr.pdf

03/06/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/31/2008 SUPPL-4 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s004ltr.pdf

02/12/1998 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
03/20/2018 SUPPL-12

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020683s012lbl.pdf
08/09/2017 SUPPL-11

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020683s011lbl.pdf
01/31/2008 SUPPL-7

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf
01/31/2008 SUPPL-6

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf
01/31/2008 SUPPL-4

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf
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