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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062341
Company: SANDOZ

Products on ANDA 062341

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062341

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/1984	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
09/15/2008	SUPPL-31	Labeling		Label is not available on this site.
12/23/2002	SUPPL-21	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/23/2001	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/28/2000	SUPPL-19	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/21/1999	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/23/1999	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/07/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/04/1999	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/01/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/18/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/18/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/12/1996	SUPPL-10	Labeling		Label is not available on this site.
10/05/1995	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/04/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/06/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/06/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/06/1990	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/05/1990	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062341

MAXITROL

SUSPENSION/DROPS;OPHTHALMIC; 0.1%;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
DEXASPORIN	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AT	064135	BAUSCH AND LOMB INC
MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OPHTHALMIC	Prescription	Yes	AT	050023	HARROW EYE
MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AT	062341	SANDOZ

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