Atropen

   
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Atropen


Drug - Atropen
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) - Atropine
Multiple ingredients are in alphabetical order.

Strength - EQ 1MG SULFATE/0.7ML
The potency of the active ingredient(s), Atropine. May repeat for multiple part products.

Applicant - MERIDIAN MEDCL TECHN
The firm name holding legal responsibility for Atropen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017106
The FDA assigned number to Atropen. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Atropen. 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 - Jun 19, 2003
The date Atropen 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 Atropen. 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 Atropen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Meridian Medical Technologies Inc
The full name of the firm holding legal responsibility for the new application of Atropen.

Atropen