Acetasol Hc

   
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Acetasol Hc


Drug - Acetasol Hc
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; Hydrocortisone
Multiple ingredients are in alphabetical order.

Strength - 2%;1%
The potency of the active ingredient(s), Acetic Acid, Glacial; Hydrocortisone. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 087143
The FDA assigned number to Acetasol Hc. Format is nnnnnn.

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

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

Approval Date - Jan 13, 1982
The date Acetasol Hc 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 Acetasol Hc. 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 Acetasol Hc 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 Acetasol Hc.

Acetasol Hc