CHEMET از شرکت RECORDATI RARE

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

CHEMET از شرکت RECORDATI RARE

New Drug Application (NDA): 019998

Company: RECORDATI RARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHEMET SUCCIMER 100MG CAPSULE;ORAL Prescription

None

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
01/30/1991 ORIG-1 Approval

Type 1 – New Molecular Entity

PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/02/2018 SUPPL-21 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019998s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019998Orig1s021ltr.pdf

07/25/2016 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/24/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/14/2010 SUPPL-17 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019998s017ltr.pdf

07/11/2007 SUPPL-13 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019998s013ltr.pdf

10/05/1999 SUPPL-11 Labeling

Label is not available on this site.

12/07/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/29/1992 SUPPL-6 Labeling

Label is not available on this site.

02/25/1992 SUPPL-4 Labeling

Label is not available on this site.

05/06/1992 SUPPL-3 Labeling

Label is not available on this site.

05/11/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/06/1991 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/02/2018 SUPPL-21

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019998s021lbl.pdf
07/11/2007 SUPPL-13

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf
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