Neo-cort-dome

   
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Neo-cort-dome


Drug - Neo-cort-dome
The trade name of the product as shown on the labeling.

Dosage - CREAM; TOPICAL
The product dosage form and route separated by a semi-colon.

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

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

Applicant - BAYER PHARMS
The firm name holding legal responsibility for Neo-cort-dome. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050237
The FDA assigned number to Neo-cort-dome. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Neo-cort-dome. 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 - Jun 5, 1984
The date Neo-cort-dome 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 Neo-cort-dome. 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 Neo-cort-dome is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Neo-cort-dome.

Neo-cort-dome