Protamine Zinc Insulin

   
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Protamine Zinc Insulin


Drug - Protamine Zinc Insulin
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) - Insulin Susp Protamine Zinc Purified Beef
Multiple ingredients are in alphabetical order.

Strength - 100 UNITS/ML
The potency of the active ingredient(s), Insulin Susp Protamine Zinc Purified Beef. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Protamine Zinc Insulin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017928
The FDA assigned number to Protamine Zinc Insulin. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Protamine Zinc Insulin. 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 Protamine Zinc Insulin 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 Protamine Zinc Insulin. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Protamine Zinc Insulin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb Co
The full name of the firm holding legal responsibility for the new application of Protamine Zinc Insulin.

Protamine Zinc Insulin