Cyproheptadine Hcl

   
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Cyproheptadine Hcl


Drug - Cyproheptadine Hcl
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Cyproheptadine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 4MG
The potency of the active ingredient(s), Cyproheptadine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 088205
The FDA assigned number to Cyproheptadine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cyproheptadine Hcl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jul 26, 1983
The date Cyproheptadine 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 Cyproheptadine 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 Cyproheptadine Hcl is in. Format is RX, OTC, DISCN.

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

Cyproheptadine Hcl