Ergomar

   
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Ergomar


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

Dosage - TABLET; SUBLINGUAL
The product dosage form and route separated by a semi-colon.

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

Strength - 2MG
The potency of the active ingredient(s), Ergotamine Tartrate. May repeat for multiple part products.

Applicant - HARVEST PHARMS
The firm name holding legal responsibility for Ergomar. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087693
The FDA assigned number to Ergomar. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ergomar. 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 24, 1983
The date Ergomar 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 Ergomar. 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 Ergomar is in. Format is RX, OTC, DISCN.

Applicant Full Name - Harvest Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Ergomar.

Ergomar