Elixomin
Drug - Elixomin
The trade name of the product as shown on the labeling.
Dosage -
ELIXIR; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Theophylline
Multiple ingredients are in alphabetical order.
Strength -
80MG/15ML
The potency of the active ingredient(s), Theophylline. May repeat for multiple part products.
Applicant -
CENCI
The firm name holding legal responsibility for Elixomin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
088303
The FDA assigned number to Elixomin. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Elixomin. 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 -
Jan 25, 1984
The date Elixomin 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 Elixomin. 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 Elixomin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Hr Cenci Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Elixomin.
Elixomin
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