Adalat Cc

   
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Adalat Cc


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

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 30MG
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 Cc. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020198
The FDA assigned number to Adalat Cc. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Adalat Cc. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB1
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Apr 21, 1993
The date Adalat Cc 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 Cc. 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 Adalat Cc 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 Cc.

Adalat Cc