Asellacrin 2

   
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Asellacrin 2


Drug - Asellacrin 2
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) - Somatropin
Multiple ingredients are in alphabetical order.

Strength - 2 IU/VIAL
The potency of the active ingredient(s), Somatropin. May repeat for multiple part products.

Applicant - SERONO
The firm name holding legal responsibility for Asellacrin 2. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017726
The FDA assigned number to Asellacrin 2. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Asellacrin 2. 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 - Jul 21, 1983
The date Asellacrin 2 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 Asellacrin 2. 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 Asellacrin 2 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Serono Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Asellacrin 2.

Asellacrin 2