Hydrocodone Compound

   
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Hydrocodone Compound


Drug - Hydrocodone Compound
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) - Homatropine Methylbromide; Hydrocodone Bitartrate
Multiple ingredients are in alphabetical order.

Strength - 1.5MG/5ML;5MG/5ML
The potency of the active ingredient(s), Homatropine Methylbromide; Hydrocodone Bitartrate. May repeat for multiple part products.

Applicant - ALPHARMA US PHARMS
The firm name holding legal responsibility for Hydrocodone Compound. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088017
The FDA assigned number to Hydrocodone Compound. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hydrocodone Compound. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AA
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jul 5, 1983
The date Hydrocodone Compound 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 Hydrocodone Compound. 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 Hydrocodone Compound is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alpharma Us Pharmaceuticals Division
The full name of the firm holding legal responsibility for the new application of Hydrocodone Compound.

Hydrocodone Compound