Naprapac 375 (copackaged)

   
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Naprapac 375 (copackaged)


Drug - Naprapac 375 (copackaged)
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Lansoprazole; Naproxen
Multiple ingredients are in alphabetical order.

Strength - 15MG,N/A;N/A,375MG
The potency of the active ingredient(s), Lansoprazole; Naproxen. May repeat for multiple part products.

Applicant - TAP PHARM
The firm name holding legal responsibility for Naprapac 375 (copackaged). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021507
The FDA assigned number to Naprapac 375 (copackaged). Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Naprapac 375 (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 - Nov 14, 2003
The date Naprapac 375 (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 Naprapac 375 (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 Naprapac 375 (copackaged) is in. Format is RX, OTC, DISCN.

Applicant Full Name - Tap Pharmaceutical Products Inc
The full name of the firm holding legal responsibility for the new application of Naprapac 375 (copackaged).

Naprapac 375 (copackaged)