Erythrocin Stearate

   
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Erythrocin Stearate


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

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

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

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

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

New Drug Application (NDA) Number - 060359
The FDA assigned number to Erythrocin Stearate. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Erythrocin Stearate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Erythrocin Stearate 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 Erythrocin Stearate. 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 Erythrocin Stearate 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 Erythrocin Stearate.

Erythrocin Stearate