Crinone

   
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Crinone


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

Dosage - GEL; VAGINAL
The product dosage form and route separated by a semi-colon.

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

Strength - 8%
The potency of the active ingredient(s), Progesterone. May repeat for multiple part products.

Applicant - COLUMBIA RES LABS
The firm name holding legal responsibility for Crinone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020701
The FDA assigned number to Crinone. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Crinone. 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 31, 1997
The date Crinone 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 Crinone. 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 Crinone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Columbia Research Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Crinone.

Crinone