Adalat

   
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Adalat


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

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 20MG
The potency of the active ingredient(s), Nifedipine. May repeat for multiple part products.

Applicant - BAYER PHARMS
The firm name holding legal responsibility for Adalat. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019478
The FDA assigned number to Adalat. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Adalat. 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 - Sep 17, 1986
The date Adalat 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 Adalat. 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 Adalat is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Adalat.

Adalat