Zinacef In Plastic Container

   
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Zinacef In Plastic Container


Drug - Zinacef 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) - Cefuroxime Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 30MG BASE/ML
The potency of the active ingredient(s), Cefuroxime Sodium. May repeat for multiple part products.

Applicant - GLAXOSMITHKLINE
The firm name holding legal responsibility for Zinacef In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050643
The FDA assigned number to Zinacef In Plastic Container. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Zinacef 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 - Apr 28, 1989
The date Zinacef 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) - Yes
The pioneer or innovator of Zinacef In Plastic Container. 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 Zinacef In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Zinacef In Plastic Container.

Zinacef In Plastic Container