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  7. Data Standards Manual (monograph) Marketing Category
  1. Data Standards Manual (monographs)

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.

Source. SPL

Relationship.

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

Data Values.

NAME DEFINITION FDA CODE
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

 

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