Pediamycin 400

   
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Pediamycin 400


Drug - Pediamycin 400
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 Ethylsuccinate
Multiple ingredients are in alphabetical order.

Strength - EQ 400MG BASE/5ML
The potency of the active ingredient(s), Erythromycin Ethylsuccinate. May repeat for multiple part products.

Applicant - ROSS LABS
The firm name holding legal responsibility for Pediamycin 400. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062304
The FDA assigned number to Pediamycin 400. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Pediamycin 400. 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 Pediamycin 400 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 Pediamycin 400. 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 Pediamycin 400 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ross Laboratories Div Abbott Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Pediamycin 400.

Pediamycin 400