Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone
Drug - Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone
The trade name of the product as shown on the labeling.
Dosage -
OINTMENT; OPHTHALMIC
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate
Multiple ingredients are in alphabetical order.
Strength -
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
The potency of the active ingredient(s), Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate. May repeat for multiple part products.
Applicant -
BAUSCH AND LOMB
The firm name holding legal responsibility for Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
064068
The FDA assigned number to Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Oct 30, 1995
The date Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".
Reference Listed Drug (RLD) -
Yes
The pioneer or innovator of Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
RX
The group or category of approved drugs Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Bausch And Lomb Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone.
Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone
Bacitracin 500 Units/gm Ointment; Ophthalmic Bacitracin 500 Units/gm Ointment; Ophthalmic Bacitracin 500 Units/gm Ointment; Topical Bacitracin 500 Units/gm Ointment; Topical Baci-rx 5,000,000 Units/bot Powder; For Rx Compounding Bacitracin 5,000,000 Units/bot Powder; For Rx Compounding Bacitracin 5,000,000 Units/bot Powder; For Rx Compounding Ziba-rx 500,000 Units/bot Powder; For Rx Compounding Cortisporin 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic
NewDrugInformation
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