Proctofoam Hc

   
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Proctofoam Hc


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

Dosage - AEROSOL, METERED; TOPICAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Hydrocortisone Acetate; Pramoxine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 1%;1%
The potency of the active ingredient(s), Hydrocortisone Acetate; Pramoxine Hydrochloride. May repeat for multiple part products.

Applicant - SCHWARZ PHARMA
The firm name holding legal responsibility for Proctofoam Hc. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 086195
The FDA assigned number to Proctofoam Hc. Format is nnnnnn.

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

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

Approval Date - Approved Prior to Jan 1, 1982
The date Proctofoam 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 Proctofoam 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 Proctofoam Hc is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schwarz Pharma Inc
The full name of the firm holding legal responsibility for the new application of Proctofoam Hc.

Proctofoam Hc