Route of Administration
INHALATION
INJECTION
INTRAMUSCULAR
INTRAVENOUS
NASAL
OPHTHALMIC
ORAL
RECTAL
SUBCUTANEOUS
SUBLINGUAL
TOPICAL
VAGINAL
Application Type
N (NDA or innovator)
A (ANDA or generic)
Therapeutic Equivalence
AA - Products in conventional dosage forms not presenting bioequivalence problems.
AB - Products meeting necessary bioequivalence requirements.
AN - Solutions and powders for aerosolization
AO - Injectable oil solutions
AP - Injectable aqueous solutions
AT - Topical Products
BC - Extended-release dosage forms (capsules, injectables and tablets)
BD - Active ingredients and dosage forms with documented bioequivalence problems
BE - Delayedrelease oral dosage forms
BN - Products in aerosolnebulizer drug delivery systems
BP - Active ingredients and dosage forms with potential bioequivalence problems
BR - Suppositories or enemas that deliver drugs for systemic absorption
BS - Products having drug standard deficiencies
BT - Topical products with bioequivalence issues
BX - Drug products for which the data are insufficient to determine therapeutic equivalence
Product Type
RX
OTC
DISC
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Nomenclature
Patents
id
Ingredient
Trade Name
DF;Route
Strength
Applicant
NDA_Type
TE
Type
RLD
RS
NDA_No
Product_No
Approval_Date
Exclusivity_Code
Exclusivity_Date
Patent_No
Patent_Expire_Date
Patent_Use_Code
Submission_Date
Applicant_Full_Name