Propranolol Hcl Intensol


Propranolol Hcl Intensol

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

Strength - 80MG/ML
The potency of the active ingredient(s), Propranolol Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 071388
The FDA assigned number to Propranolol Hcl Intensol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Propranolol Hcl Intensol. 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 - May 15, 1987
The date Propranolol Hcl Intensol 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 Propranolol Hcl Intensol. 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 Propranolol Hcl Intensol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Roxane Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Propranolol Hcl Intensol.

Propranolol Hcl Intensol