Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 064064
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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 AT No 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
10/30/1995 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-11 Manufacturing (CMC)-Facility

Label is not available on this site.

11/27/2001 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/07/2001 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/27/2000 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/28/2000 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/07/1999 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/03/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/29/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/30/1999 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1998 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/15/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

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