Pravigard Pac (copackaged)

   
Google
 
Web NewDrugInformation.com

Pravigard Pac (copackaged)


Drug - Pravigard Pac (copackaged)
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Aspirin; Pravastatin Sodium
Multiple ingredients are in alphabetical order.

Strength - 325MG,N/A;N/A,40MG
The potency of the active ingredient(s), Aspirin; Pravastatin Sodium. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Pravigard Pac (copackaged). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021387
The FDA assigned number to Pravigard Pac (copackaged). Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Pravigard Pac (copackaged). 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 - Jun 24, 2003
The date Pravigard Pac (copackaged) 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 Pravigard Pac (copackaged). 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 Pravigard Pac (copackaged) is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb Co
The full name of the firm holding legal responsibility for the new application of Pravigard Pac (copackaged).

Pravigard Pac (copackaged)