Bromocriptine Mesylate

   
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Bromocriptine Mesylate


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

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

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

Strength - EQ 2.5MG BASE
The potency of the active ingredient(s), Bromocriptine Mesylate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 074631
The FDA assigned number to Bromocriptine Mesylate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Bromocriptine Mesylate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jan 13, 1998
The date Bromocriptine Mesylate 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 Bromocriptine Mesylate. 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 Bromocriptine Mesylate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Lek Pharmaceuticals D D
The full name of the firm holding legal responsibility for the new application of Bromocriptine Mesylate.

Bromocriptine Mesylate