Alphacaine Hcl
Drug - Alphacaine 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) -
Lidocaine Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
2%
The potency of the active ingredient(s), Lidocaine Hydrochloride. May repeat for multiple part products.
Applicant -
CARLISLE
The firm name holding legal responsibility for Alphacaine Hcl. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
084721
The FDA assigned number to Alphacaine Hcl. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Alphacaine 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 -
Approved Prior to Jan 1, 1982
The date Alphacaine 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 Alphacaine 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 Alphacaine Hcl is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Carlisle Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Alphacaine Hcl.
Alphacaine Hcl
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