Methyldopate Hcl

   
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Methyldopate Hcl


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

Strength - 50MG/ML
The potency of the active ingredient(s), Methyldopate Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 072974
The FDA assigned number to Methyldopate Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Methyldopate 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 - Nov 22, 1991
The date Methyldopate 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 Methyldopate 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 Methyldopate Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sicor Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Methyldopate Hcl.

Methyldopate Hcl