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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064063
Company: BAUSCH AND LOMB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;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
07/25/1994 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
02/07/2020 SUPPL-42 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
02/07/2020 SUPPL-41 Labeling-Package Insert

Label is not available on this site.
08/27/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
08/27/2002 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.
08/21/2002 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/05/2002 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.
11/27/2001 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/07/2001 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/27/2000 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
08/21/2000 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
04/28/2000 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/07/1999 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
02/11/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
11/16/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
03/30/1999 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
04/10/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
10/22/1998 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
07/23/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
07/23/1997 SUPPL-4 Labeling

Label is not available on this site.
07/23/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
10/04/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
01/31/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

OINTMENT;OPHTHALMIC; 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAXITROL DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription Yes AT 050065 SANDOZ
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 064063 BAUSCH AND LOMB
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 062938 PADAGIS US
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