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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011340
Company: PHARM RES ASSOC

Products on NDA 011340

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CERUMENEX	TROLAMINE POLYPEPTIDE OLEATE CONDENSATE	10%	SOLUTION/DROPS;OTIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011340

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/1958	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2002	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11340s16ltr.pdf
11/09/2000	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/09/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/09/2000	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/09/2000	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/09/2000	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/09/2000	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/11/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/21/1991	SUPPL-8	Labeling		Label is not available on this site.
12/02/1988	SUPPL-7	Labeling		Label is not available on this site.
06/04/1981	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/07/1977	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 011340

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2002	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf

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