Pharmaceutical

Pharmaceutical

Relating to the development, production and marketing of drugs that are legal and licensed for use as medication.

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Pharmaceutical > Drugs

approval history

Pharmaceutical; Drugs

The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval ...

approval letter

Pharmaceutical; Drugs

An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.

biologic license application (BLA)

Pharmaceutical; Drugs

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in ...

biological product

Pharmaceutical; Drugs

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic ...

brand name drug

Pharmaceutical; Drugs

A brand name drug is a drug marketed under a proprietary, trademark-protected name.

chemical type

Pharmaceutical; Drugs

The Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation. For example, Chemical Type 1 is assigned to an active ...