Otocort

   
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Otocort


Drug - Otocort
The trade name of the product as shown on the labeling.

Dosage - SUSPENSION/DROPS; OTIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate
Multiple ingredients are in alphabetical order.

Strength - 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
The potency of the active ingredient(s), Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate. May repeat for multiple part products.

Applicant - STERIS
The firm name holding legal responsibility for Otocort. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062521
The FDA assigned number to Otocort. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Otocort. 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 11, 1985
The date Otocort 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 Otocort. 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 Otocort is in. Format is RX, OTC, DISCN.

Applicant Full Name - Steris Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Otocort.

Otocort


Neomycin And Polymyxin B Sulfates And Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic
Neomycin Sulfate, Polymyxin B Sulfate & Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic
Oticair 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic
Oticair 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic
Otobione 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic
Otocort 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic
Cortisporin 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic
Neomycin And Polymyxin B Sulfates And Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic
Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic
Cortisporin 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic

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