Pepcid Complete

   
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Pepcid Complete


Drug - Pepcid Complete
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) - Calcium Carbonate; Famotidine; Magnesium Hydroxide
Multiple ingredients are in alphabetical order.

Strength - 800MG;10MG;165MG
The potency of the active ingredient(s), Calcium Carbonate; Famotidine; Magnesium Hydroxide. May repeat for multiple part products.

Applicant - MERCK
The firm name holding legal responsibility for Pepcid Complete. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020958
The FDA assigned number to Pepcid Complete. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Pepcid Complete. 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 - Oct 16, 2000
The date Pepcid Complete 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) - Yes
The pioneer or innovator of Pepcid Complete. 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 Pepcid Complete is in. Format is RX, OTC, DISCN.

Applicant Full Name - Merck Research Laboratories Div Merck Co Inc
The full name of the firm holding legal responsibility for the new application of Pepcid Complete.

Pepcid Complete