Clindamycin Hydrochloride

   
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Clindamycin Hydrochloride


Drug - Clindamycin Hydrochloride
The trade name of the product as shown on the labeling.

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

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

Strength - EQ 150MG BASE
The potency of the active ingredient(s), Clindamycin Hydrochloride. May repeat for multiple part products.

Applicant - ZYDUS PHARMS USA
The firm name holding legal responsibility for Clindamycin Hydrochloride. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 065217
The FDA assigned number to Clindamycin Hydrochloride. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Clindamycin Hydrochloride. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jan 31, 2005
The date Clindamycin Hydrochloride 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 Clindamycin Hydrochloride. 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 Clindamycin Hydrochloride is in. Format is RX, OTC, DISCN.

Applicant Full Name - Zydus Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Clindamycin Hydrochloride.

Clindamycin Hydrochloride