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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064135
Company: BAUSCH AND LOMB

Products on ANDA 064135

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXASPORIN	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 064135

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/1995	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
07/21/2023	SUPPL-42	Labeling-Package Insert		Label is not available on this site.
02/07/2020	SUPPL-34	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
02/05/2002	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
11/27/2001	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/07/2001	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/27/2000	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/21/2000	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/02/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
04/28/2000	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/02/1999	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
11/19/1998	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/10/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/11/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/19/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/14/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064135

DEXASPORIN

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
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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