Drugs@FDA: FDA Approved Drug Products

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

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 NOVARTIS
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 INC

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