Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 060613
Company: CASPER PHARMA LLC

Products on NDA 060613

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CASPORYN HC	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 060613

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/1975	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2017	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060613s013lbl.pdf
07/23/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/10/2000	SUPPL-9	Labeling		Label is not available on this site.
08/10/2000	SUPPL-8	Labeling		Label is not available on this site.
02/14/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/30/1993	SUPPL-5	Labeling		Label is not available on this site.
02/04/1988	SUPPL-4	Labeling		Label is not available on this site.

Labels for NDA 060613

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2017	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060613s013lbl.pdf

Therapeutic Equivalents for NDA 060613

CASPORYN HC

SUSPENSION/DROPS;OTIC; 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CASPORYN HC	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	Yes	AT	060613	CASPER PHARMA LLC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	No	AT	065219	AMRING PHARMS
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	No	AT	062488	SANDOZ
OTICAIR	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	No	AT	064065	BAUSCH AND LOMB