Clomiphene Citrate
Drug - Clomiphene Citrate
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) -
Clomiphene Citrate
Multiple ingredients are in alphabetical order.
Strength -
50MG
The potency of the active ingredient(s), Clomiphene Citrate. May repeat for multiple part products.
Applicant -
PAR PHARM
The firm name holding legal responsibility for Clomiphene Citrate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
075528
The FDA assigned number to Clomiphene Citrate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Clomiphene Citrate. 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 -
Aug 30, 1999
The date Clomiphene Citrate 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 Clomiphene Citrate. 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 Clomiphene Citrate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Par Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Clomiphene Citrate.
Clomiphene Citrate
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