Diastat Acudial

   
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Diastat Acudial


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

Dosage - GEL; RECTAL
The product dosage form and route separated by a semi-colon.

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

Strength - 20MG/4ML (5MG/ML)
The potency of the active ingredient(s), Diazepam. May repeat for multiple part products.

Applicant - VALEANT
The firm name holding legal responsibility for Diastat Acudial. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020648
The FDA assigned number to Diastat Acudial. Format is nnnnnn.

Product Number - 006
The FDA assigned number to identify Diastat Acudial. 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 - Sep 15, 2005
The date Diastat Acudial 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 Diastat Acudial. 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 Diastat Acudial is in. Format is RX, OTC, DISCN.

Applicant Full Name - Valeant Pharmaceuticals International
The full name of the firm holding legal responsibility for the new application of Diastat Acudial.

Diastat Acudial