Ophthocort

   
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Ophthocort


Drug - Ophthocort
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) - Chloramphenicol; Hydrocortisone Acetate; Polymyxin B Sulfate
Multiple ingredients are in alphabetical order.

Strength - 10MG/GM;5MG/GM;10,000 UNITS/GM
The potency of the active ingredient(s), Chloramphenicol; Hydrocortisone Acetate; Polymyxin B Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050201
The FDA assigned number to Ophthocort. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Ophthocort. 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 - Approved Prior to Jan 1, 1982
The date Ophthocort 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 Ophthocort. 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 Ophthocort is in. Format is RX, OTC, DISCN.

Applicant Full Name - Parkedale Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Ophthocort.

Ophthocort