Aureomycin
Drug - Aureomycin
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) -
Chlortetracycline Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
1%
The potency of the active ingredient(s), Chlortetracycline Hydrochloride. May repeat for multiple part products.
Applicant -
LEDERLE
The firm name holding legal responsibility for Aureomycin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
050404
The FDA assigned number to Aureomycin. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Aureomycin. 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 Aureomycin 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 Aureomycin. 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 Aureomycin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Lederle Laboratories Div American Cyanamid Co
The full name of the firm holding legal responsibility for the new application of Aureomycin.
Aureomycin
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