Hydrocodone Bitartrate And Ibuprofen

   
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Hydrocodone Bitartrate And Ibuprofen


Drug - Hydrocodone Bitartrate And Ibuprofen
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) - Hydrocodone Bitartrate; Ibuprofen
Multiple ingredients are in alphabetical order.

Strength - 7.5MG;200MG
The potency of the active ingredient(s), Hydrocodone Bitartrate; Ibuprofen. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 076604
The FDA assigned number to Hydrocodone Bitartrate And Ibuprofen. Format is nnnnnn.

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

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

Approval Date - Dec 31, 2003
The date Hydrocodone Bitartrate And Ibuprofen 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 Hydrocodone Bitartrate And Ibuprofen. 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 Ibuprofen is in. Format is RX, OTC, DISCN.

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

Hydrocodone Bitartrate And Ibuprofen