Nalbuphine Hcl

   
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Nalbuphine Hcl


Drug - Nalbuphine Hcl
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Nalbuphine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 10MG/ML
The potency of the active ingredient(s), Nalbuphine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 072071
The FDA assigned number to Nalbuphine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nalbuphine Hcl. 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 - Apr 10, 1989
The date Nalbuphine 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 Nalbuphine Hcl. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Nalbuphine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Lp
The full name of the firm holding legal responsibility for the new application of Nalbuphine Hcl.

Nalbuphine Hcl