Data Standards Manual (monograph) Marketing Category
FDA Data Element Number. Pending.
CDER Data Element Number. C-DRG-0935
Data Element Name. MARKETING CATEGORY
Data Element NCI ConceptID: C73581
Version Number. 001
Description. The listing entity’s description of the product and/or regulatory justification for placing a product on the market.
FDA Specifications. No further specifications.
CDER Specifications. No further specifications.
FDA Approved Date. March 28, 2008
CDER Approved Date. March 28, 2008
FDA Revised Date. July 31, 2008
CDER Revised Date. July 31, 2008
|ANADA||A product marketed under an approved Abbreviated New Animal Drug Application||C73583|
|ANDA||A product marketed under an approved Abbreviated New Drug Application||C73584|
|BLA||A product marketed under an approved Biologic License Application||C73585|
|BULK INGREDIENT||Marketed as a bulk ingredient||C73626|
|CONDITIONAL NADA||A product marketed under a conditional New Animal Drug Application||C73588|
|EXPORT ONLY||A product that is only exported and not marketed in the United States||C73590|
|IND||A product marketed for research use only under an active Investigational New Drug Application||C75302|
|NADA||A product marketed under an approved New Animal Drug Application||C73593|
|NDA||A product marketed under an approved New Drug Application||C73594|
|NDA AUTHORIZED GENERIC||A product marketed as a “generic” drug under an approved NDA, rather than an ANDA||C73605|
|OTC MONOGRAPH FINAL||A product marketed pursuant to a final OTC Drug Monograph||C73603|
|OTC MONOGRAPH NOT FINAL||A product marketed pursuant to an OTC Drug Monograph that is not final.||C73604|
|UNAPPROVED OTHER MARKETING CATEGORY||Unapproved other Marketing Category||C73627|