Bentyl Preservative Free

   
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Bentyl Preservative Free


Drug - Bentyl Preservative Free
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) - Dicyclomine Hydrochloride
Multiple ingredients are in alphabetical order.

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

Applicant - AXCAN SCANDIPHARM
The firm name holding legal responsibility for Bentyl Preservative Free. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 008370
The FDA assigned number to Bentyl Preservative Free. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Bentyl Preservative Free. 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 - Oct 15, 1984
The date Bentyl Preservative Free 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 Bentyl Preservative Free. 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 Bentyl Preservative Free is in. Format is RX, OTC, DISCN.

Applicant Full Name - Axcan Scandipharm Inc
The full name of the firm holding legal responsibility for the new application of Bentyl Preservative Free.

Bentyl Preservative Free