Acetadote

   
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Acetadote


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

Dosage - INJECTABLE; INTRAVENOUS
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Acetylcysteine
Multiple ingredients are in alphabetical order.

Strength - 6GM/30ML (200MG/ML)
The potency of the active ingredient(s), Acetylcysteine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021539
The FDA assigned number to Acetadote. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acetadote. 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 23, 2004
The date Acetadote 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 Acetadote. 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 Acetadote is in. Format is RX, OTC, DISCN.

Applicant Full Name - Cumberland Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Acetadote.

Acetadote