Acetic Acid

   
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Acetic Acid


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

Dosage - SOLUTION/DROPS; OTIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Acetic Acid, Glacial
Multiple ingredients are in alphabetical order.

Strength - 2%
The potency of the active ingredient(s), Acetic Acid, Glacial. May repeat for multiple part products.

Applicant - KV PHARM
The firm name holding legal responsibility for Acetic Acid. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 085493
The FDA assigned number to Acetic Acid. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acetic Acid. 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 - Approved Prior to Jan 1, 1982
The date Acetic Acid 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 Acetic Acid. 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 Acetic Acid is in. Format is RX, OTC, DISCN.

Applicant Full Name - Kv Pharmaceutical Co
The full name of the firm holding legal responsibility for the new application of Acetic Acid.

Acetic Acid