Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065022
Company: PADAGIS US

Products on ANDA 065022

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065022

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2002	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
08/15/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065022

BACITRACIN ZINC AND POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC; 500 UNITS/GM;10,000 UNITS/GM
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	No	AT	064046	BAUSCH AND LOMB
BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	No	AT	065022	PADAGIS US
BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	No	AT	064028	SAPTALIS PHARMS