Ammonul

   
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Ammonul


Drug - Ammonul
The trade name of the product as shown on the labeling.

Dosage - SOLUTION; IV (INFUSION)
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Sodium Benzoate; Sodium Phenylacetate
Multiple ingredients are in alphabetical order.

Strength - 10%;10% (5GM/50ML;5GM/50ML)
The potency of the active ingredient(s), Sodium Benzoate; Sodium Phenylacetate. May repeat for multiple part products.

Applicant - UCYCLYD
The firm name holding legal responsibility for Ammonul. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020645
The FDA assigned number to Ammonul. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ammonul. 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 - Feb 17, 2005
The date Ammonul 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) - Yes
The pioneer or innovator of Ammonul. 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 Ammonul is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ucyclyd Pharma Inc
The full name of the firm holding legal responsibility for the new application of Ammonul.

Ammonul