Rocephin W/ Dextrose In Plastic Container

   
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Rocephin W/ Dextrose In Plastic Container


Drug - Rocephin W/ Dextrose In Plastic Container
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 10MG BASE/ML
The potency of the active ingredient(s), Ceftriaxone Sodium. May repeat for multiple part products.

Applicant - HLR
The firm name holding legal responsibility for Rocephin W/ Dextrose In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050624
The FDA assigned number to Rocephin W/ Dextrose In Plastic Container. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Rocephin W/ Dextrose In Plastic Container. 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 - Feb 11, 1987
The date Rocephin W/ Dextrose In Plastic Container 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 Rocephin W/ Dextrose In Plastic Container. 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 Rocephin W/ Dextrose In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hlr Technology
The full name of the firm holding legal responsibility for the new application of Rocephin W/ Dextrose In Plastic Container.

Rocephin W/ Dextrose In Plastic Container