Drugs@FDA: FDA Approved Drug Products

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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
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
07/11/2007 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf

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