Anexsia 7.5/650


Anexsia 7.5/650

Drug - Anexsia 7.5/650
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Acetaminophen; Hydrocodone Bitartrate
Multiple ingredients are in alphabetical order.

Strength - 650MG;7.5MG
The potency of the active ingredient(s), Acetaminophen; Hydrocodone Bitartrate. May repeat for multiple part products.

The firm name holding legal responsibility for Anexsia 7.5/650. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 089725
The FDA assigned number to Anexsia 7.5/650. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Anexsia 7.5/650. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Sep 30, 1987
The date Anexsia 7.5/650 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 Anexsia 7.5/650. 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 Anexsia 7.5/650 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mallinckrodt Chemical Inc
The full name of the firm holding legal responsibility for the new application of Anexsia 7.5/650.

Anexsia 7.5/650