Flagyl Er

   
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Flagyl Er


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

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 750MG
The potency of the active ingredient(s), Metronidazole. May repeat for multiple part products.

Applicant - GD SEARLE LLC
The firm name holding legal responsibility for Flagyl Er. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020868
The FDA assigned number to Flagyl Er. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Flagyl Er. 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 - Nov 26, 1997
The date Flagyl Er 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 Flagyl Er. 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 Flagyl Er is in. Format is RX, OTC, DISCN.

Applicant Full Name - Gd Searle Llc
The full name of the firm holding legal responsibility for the new application of Flagyl Er.

Flagyl Er