Cysteine Hcl


Cysteine Hcl

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

Strength - 7.25%
The potency of the active ingredient(s), Cysteine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019523
The FDA assigned number to Cysteine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cysteine 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 - Oct 22, 1986
The date Cysteine 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 Cysteine 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 Cysteine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hospira Inc
The full name of the firm holding legal responsibility for the new application of Cysteine Hcl.

Cysteine Hcl