Coly-mycin S

   
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Coly-mycin S


Drug - Coly-mycin S
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) - Colistin Sulfate; Hydrocortisone Acetate; Neomycin Sulfate; Thonzonium Bromide
Multiple ingredients are in alphabetical order.

Strength - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
The potency of the active ingredient(s), Colistin Sulfate; Hydrocortisone Acetate; Neomycin Sulfate; Thonzonium Bromide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050356
The FDA assigned number to Coly-mycin S. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Coly-mycin S. 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 Coly-mycin S 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 Coly-mycin S. 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 Coly-mycin S 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 Coly-mycin S.

Coly-mycin S