Pce

   
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Pce


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

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

Active Ingredient(s) - Erythromycin
Multiple ingredients are in alphabetical order.

Strength - 500MG
The potency of the active ingredient(s), Erythromycin. May repeat for multiple part products.

Applicant - ABBOTT
The firm name holding legal responsibility for Pce. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050611
The FDA assigned number to Pce. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Pce. 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 - Aug 22, 1990
The date Pce 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 Pce. 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 Pce is in. Format is RX, OTC, DISCN.

Applicant Full Name - Abbott Laboratories Pharmaceutical Products Div
The full name of the firm holding legal responsibility for the new application of Pce.

Pce