Testoderm Tts

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Testoderm Tts

Drug - Testoderm Tts
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Testosterone
Multiple ingredients are in alphabetical order.

Strength - 5MG/24HR
The potency of the active ingredient(s), Testosterone. May repeat for multiple part products.

Applicant - ALZA
The firm name holding legal responsibility for Testoderm Tts. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020791
The FDA assigned number to Testoderm Tts. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Testoderm Tts. 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 - Dec 18, 1997
The date Testoderm Tts 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 Testoderm Tts. 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 Testoderm Tts is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alza Corp
The full name of the firm holding legal responsibility for the new application of Testoderm Tts.

Testoderm Tts