Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050417
Company: CASPER PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOSPORIN BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription AT Yes 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
05/10/1971 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
04/30/2004 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50417slr011_neosporin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50417slr011ltr.pdf
04/19/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/23/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/09/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/10/1994 SUPPL-4 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/2004 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50417slr011_neosporin_lbl.pdf

NEOSPORIN

OINTMENT;OPHTHALMIC; 400 UNITS/GM;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
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 065088 AKORN
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 064064 BAUSCH AND LOMB
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 060764 PERRIGO CO TENNESSEE
NEOSPORIN BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription Yes AT 050417 CASPER PHARMA LLC

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