Monocid

   
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Monocid


Drug - Monocid
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) - Cefonicid Sodium
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 050579
The FDA assigned number to Monocid. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Monocid. 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 - May 23, 1984
The date Monocid 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 Monocid. 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 Monocid 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 Monocid.

Monocid