Hydromorphone Hcl

   
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Hydromorphone Hcl


Drug - Hydromorphone Hcl
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) - Hydromorphone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 8MG
The potency of the active ingredient(s), Hydromorphone Hydrochloride. May repeat for multiple part products.

Applicant - KV PHARM
The firm name holding legal responsibility for Hydromorphone Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 077311
The FDA assigned number to Hydromorphone Hcl. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Hydromorphone Hcl. 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 - Nov 9, 2005
The date Hydromorphone Hcl 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 Hydromorphone Hcl. 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 Hydromorphone Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Kv Pharmaceutical Co
The full name of the firm holding legal responsibility for the new application of Hydromorphone Hcl.

Hydromorphone Hcl