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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050417
Company: CASPER PHARMA LLC

Products on NDA 050417

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMI-SPORYN	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	AT	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050417

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/1971	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
05/21/2020	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050417s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050417Orig1s012ltr.pdf
04/30/2004	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50417slr011_neosporin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50417slr011ltr.pdf
04/19/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/23/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/09/1995	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/22/1993	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
03/23/1993	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/10/1992	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/10/1994	SUPPL-4	Labeling		Label is not available on this site.

Labels for NDA 050417

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050417s012lbl.pdf
05/21/2020	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050417s012lbl.pdf
04/30/2004	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50417slr011_neosporin_lbl.pdf

Therapeutic Equivalents for NDA 050417

LUMI-SPORYN

OINTMENT;OPHTHALMIC; EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LUMI-SPORYN	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	Yes	AT	050417	CASPER PHARMA LLC

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