Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone
Drug - Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & 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 -
PHARMAFAIR
The firm name holding legal responsibility for Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
062389
The FDA assigned number to Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Jul 2, 1982
The date Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & 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) -
No
The pioneer or innovator of Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Pharmafair Inc
The full name of the firm holding legal responsibility for the new application of Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone.
Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone
Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 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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