Hycomine Pediatric

   
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Hycomine Pediatric


Drug - Hycomine 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) - Hydrocodone Bitartrate; Phenylpropanolamine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 2.5MG/5ML;12.5MG/5ML
The potency of the active ingredient(s), Hydrocodone Bitartrate; Phenylpropanolamine Hydrochloride. May repeat for multiple part products.

Applicant - ENDO PHARMS
The firm name holding legal responsibility for Hycomine Pediatric. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019411
The FDA assigned number to Hycomine Pediatric. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hycomine 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 - Aug 17, 1990
The date Hycomine 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 Hycomine 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 Hycomine Pediatric is in. Format is RX, OTC, DISCN.

Applicant Full Name - Endo Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Hycomine Pediatric.

Hycomine Pediatric