Oxtriphylline Pediatric
Drug - Oxtriphylline Pediatric
The trade name of the product as shown on the labeling.
Dosage -
SYRUP; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Oxtriphylline
Multiple ingredients are in alphabetical order.
Strength -
50MG/5ML
The potency of the active ingredient(s), Oxtriphylline. May repeat for multiple part products.
Applicant -
MORTON GROVE
The firm name holding legal responsibility for Oxtriphylline Pediatric. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
088242
The FDA assigned number to Oxtriphylline Pediatric. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Oxtriphylline Pediatric. 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 -
Dec 5, 1983
The date Oxtriphylline Pediatric 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 Oxtriphylline Pediatric. 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 Oxtriphylline Pediatric is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Morton Grove Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Oxtriphylline Pediatric.
Oxtriphylline Pediatric
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