Erythromycin Estolate

   
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Erythromycin Estolate


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

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

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

Strength - EQ 250MG BASE/5ML
The potency of the active ingredient(s), Erythromycin Estolate. May repeat for multiple part products.

Applicant - LIFE LABS
The firm name holding legal responsibility for Erythromycin Estolate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062362
The FDA assigned number to Erythromycin Estolate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Erythromycin Estolate. 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 - Dec 17, 1982
The date Erythromycin Estolate 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 Erythromycin Estolate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Life Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Erythromycin Estolate.

Erythromycin Estolate