Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005939
Company: PROVEPHARM SAS

Products on NDA 005939

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BAL	DIMERCAPROL	10%	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 005939

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/1946	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/08/2022	SUPPL-12	Manufacturing (CMC)-Manufacturing Process	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/005939Orig1s012;011525Orig1s031;012015Orig1s036;016619Orig1s045;019353Orig1s024;208609Orig1s006correctedltr.pdf
04/18/2007	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005939s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/05939s007Ltr.pdf
09/26/2006	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/27/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/29/1977	SUPPL-2	Labeling		Label is not available on this site.

Labels for NDA 005939

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2007	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005939s007lbl.pdf