Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050065
Company: NOVARTIS
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/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/19/1963 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/18/2017 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050065Orig1s064ltr.pdf
04/12/2017 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050065Orig1s061ltr.pdf
10/06/2015 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

12/10/2012 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

12/18/2012 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

07/15/2004 SUPPL-44 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50065s043,044ltr.pdf
07/15/2004 SUPPL-43 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50065s043,044ltr.pdf
12/11/2002 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/2003 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50065slr040,scm039ltr.pdf
07/23/2003 SUPPL-39 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50065slr040,scm039ltr.pdf
02/09/2001 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/28/1999 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/1999 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/29/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/29/1996 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1995 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/30/1995 SUPPL-29 Labeling

Label is not available on this site.

07/11/1983 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1982 SUPPL-27 Labeling

Label is not available on this site.

06/17/1981 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1978 SUPPL-24 Labeling

Label is not available on this site.

02/20/1973 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1973 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1973 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1972 SUPPL-20 Labeling

Label is not available on this site.

07/12/1972 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1972 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1972 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/1971 SUPPL-16 Labeling

Label is not available on this site.

07/22/1971 SUPPL-15 Labeling

Label is not available on this site.

06/04/1970 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1992 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1992 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/22/1988 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1987 SUPPL-8 Labeling

Label is not available on this site.

06/30/1987 SUPPL-7 Labeling

Label is not available on this site.

06/30/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/25/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1983 SUPPL-3 Labeling

Label is not available on this site.

11/23/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1983 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/2017 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s064lbl.pdf
04/12/2017 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s061lbl.pdf
07/15/2004 SUPPL-44 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf
07/15/2004 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf
07/23/2003 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf
07/23/2003 SUPPL-39 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf

MAXITROL

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 NOVARTIS
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 PERRIGO CO TENNESSEE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English