Prostin F2 Alpha

   
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Prostin F2 Alpha


Drug - Prostin F2 Alpha
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) - Dinoprost Tromethamine
Multiple ingredients are in alphabetical order.

Strength - EQ 5MG BASE/ML
The potency of the active ingredient(s), Dinoprost Tromethamine. May repeat for multiple part products.

Applicant - PHARMACIA AND UPJOHN
The firm name holding legal responsibility for Prostin F2 Alpha. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017434
The FDA assigned number to Prostin F2 Alpha. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Prostin F2 Alpha. 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 Prostin F2 Alpha 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 Prostin F2 Alpha. 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 Prostin F2 Alpha 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 Prostin F2 Alpha.

Prostin F2 Alpha