Hydrocodone Bitartrate And Acetaminophen

   
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Hydrocodone Bitartrate And Acetaminophen


Drug - Hydrocodone Bitartrate And Acetaminophen
The trade name of the product as shown on the labeling.

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

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

Strength - 400MG;10MG
The potency of the active ingredient(s), Acetaminophen; Hydrocodone Bitartrate. May repeat for multiple part products.

Applicant - ENDO PHARMS
The firm name holding legal responsibility for Hydrocodone Bitartrate And Acetaminophen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 040288
The FDA assigned number to Hydrocodone Bitartrate And Acetaminophen. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Hydrocodone Bitartrate And Acetaminophen. 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 27, 1998
The date Hydrocodone Bitartrate And Acetaminophen 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) - Yes
The pioneer or innovator of Hydrocodone Bitartrate And Acetaminophen. 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 Hydrocodone Bitartrate And Acetaminophen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Endo Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Hydrocodone Bitartrate And Acetaminophen.

Hydrocodone Bitartrate And Acetaminophen