R-gene 10

   
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R-gene 10


Drug - R-gene 10
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) - Arginine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 10GM/100ML
The potency of the active ingredient(s), Arginine Hydrochloride. May repeat for multiple part products.

Applicant - PHARMACIA AND UPJOHN
The firm name holding legal responsibility for R-gene 10. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016931
The FDA assigned number to R-gene 10. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify R-gene 10. 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 - Approved Prior to Jan 1, 1982
The date R-gene 10 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 R-gene 10. 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 R-gene 10 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmacia And Upjohn Co
The full name of the firm holding legal responsibility for the new application of R-gene 10.

R-gene 10