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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019998
Company: RECORDATI RARE

Products on NDA 019998

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHEMET	SUCCIMER	100MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019998

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.

Labels for NDA 019998

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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