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The firm holding legal responsibility for the new drug application.
The trade name of the product as shown on the labeling.
Generic Name / Ingredient
The active ingredient(s) for the product. Multiple ingredients are in alphabetical order separated by a semicolon.
New Drug Application (NDA) Number
The FDA-assigned number to the application.
The FDA-assigned number to identify the application products. Each strength is a separate product.
The date the product was approved as stated in the FDA approval letter to the applicant.
The group or category of approved drugs; RX, OTC, or DISCN.
Reference Listed Drug (RLD)
The pioneer or innovator of the drug. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. The RLD must be a listed drug approved under section 505(c) of the FD&C Act based on a demonstration of safety and effectiveness.
The previously approved drug selected by FDA that an applicant must use in the conduct of in vivo bioequivalence studies required for approval of an ANDA. The reference standard may or may not be the same listed drug as the RLD.
Drug Product Flag
Patents listed after August 18, 2003 may have a drug product flag indicating the sponsor submitted the patent as claiming the drug product. The FDA defines a drug product as a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients
Drug Substance Flag
Patents listed after August 18, 2003 may have a drug substance flag indicating the sponsor submitted the patent as claiming the drug substance. The FDA defines a drug substance as an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.
Patent Delist Request Flag
Sponsor has requested patent be delisted. This patent has remained listed because a first applicant may retain eligibility for 180-day exclusivity based on a paragraph IV certification.
Patent numbers as submitted to the FDA by the applicant, who may not be the patent-assignee. A '*PED' tag indicates pediatric exclusivity granted by the FDA.
Patent Expiration Date
The date the patent expires as submitted by the applicant holder, including applicable extensions. A '*PED' tag indicates pediatric exclusivity granted by the FDA.
Dosage form; Route of Administration
The product dosage form and route separated by a semi-colon.
The potency of the active ingredient. May repeat for multiple part products.
Therapeutic Equivalence (TE) Code
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
The two basic categories into which multisource drugs have been placed are indicated by the first letter as follows:
Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which:
- there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or
- actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence. These are designated AB.
Drug products that FDA at this time, considers NOT to be therapeutically equivalent to other pharmaceutically equivalent products, i.e.,
- drug products for which actual or potential bioequivalence
problems have not been resolved by adequate evidence of bioequivalence.
Often the problem is with specific dosage forms rather than with the
active ingredients. These are designated BC, BD, BE, BN, BP, BR, BS,
BT, BX, or B*.
Patented / Exclusive Use
Designation to designate exclusivity granted to a drug product.
Exclusivity Expiration Date
The date the exclusivity expires.
If a generic drug product is ready for approval before the expiration of any patents or exclusivities, the FDA issues a tentative approval letter to the applicant. Final approval of the generic drug product is delayed until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product.