Atracurium Besylate

   
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Atracurium Besylate


Drug - Atracurium Besylate
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) - Atracurium Besylate
Multiple ingredients are in alphabetical order.

Strength - 10MG/ML
The potency of the active ingredient(s), Atracurium Besylate. May repeat for multiple part products.

Applicant - MARSAM PHARMS LLC
The firm name holding legal responsibility for Atracurium Besylate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074945
The FDA assigned number to Atracurium Besylate. Format is nnnnnn.

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

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

Approval Date - Jul 28, 1998
The date Atracurium Besylate 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 Atracurium Besylate. 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 Atracurium Besylate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Marsam Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Atracurium Besylate.

Atracurium Besylate