Acetylcysteine

   
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Acetylcysteine


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

Dosage - SOLUTION; INHALATION, ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 20%
The potency of the active ingredient(s), Acetylcysteine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 072324
The FDA assigned number to Acetylcysteine. Format is nnnnnn.

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

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

Approval Date - Apr 30, 1992
The date Acetylcysteine 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 Acetylcysteine. 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 Acetylcysteine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bedford Laboratories Div Ben Venue Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Acetylcysteine.

Acetylcysteine