Drugs@FDA: FDA-Approved Drugs

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

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
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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