Vancomycin Hcl

   
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Vancomycin Hcl


Drug - Vancomycin 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) - Vancomycin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 5GM BASE/VIAL
The potency of the active ingredient(s), Vancomycin Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 062663
The FDA assigned number to Vancomycin Hcl. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Vancomycin Hcl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jun 3, 1988
The date Vancomycin 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) - Yes
The pioneer or innovator of Vancomycin 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 Vancomycin Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - American Pharmaceutical Partners Inc
The full name of the firm holding legal responsibility for the new application of Vancomycin Hcl.

Vancomycin Hcl