Eryc

   
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Eryc


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

Dosage - CAPSULE, DELAYED REL PELLETS; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 250MG
The potency of the active ingredient(s), Erythromycin. May repeat for multiple part products.

Applicant - MAYNE PHARMA USA
The firm name holding legal responsibility for Eryc. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050536
The FDA assigned number to Eryc. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Eryc. 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 Eryc 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 Eryc. 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 Eryc is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mayne Pharma Usa Inc
The full name of the firm holding legal responsibility for the new application of Eryc.

Eryc