Foamcoat

   
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Foamcoat


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

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

Active Ingredient(s) - Aluminum Hydroxide; Magnesium Trisilicate
Multiple ingredients are in alphabetical order.

Strength - 80MG;20MG
The potency of the active ingredient(s), Aluminum Hydroxide; Magnesium Trisilicate. May repeat for multiple part products.

Applicant - GUARDIAN DRUG
The firm name holding legal responsibility for Foamcoat. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 071793
The FDA assigned number to Foamcoat. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Foamcoat. 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 - Sep 4, 1987
The date Foamcoat 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 Foamcoat. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Foamcoat is in. Format is RX, OTC, DISCN.

Applicant Full Name - Guardian Drug Co Inc
The full name of the firm holding legal responsibility for the new application of Foamcoat.

Foamcoat