BUSPIRONE HYDROCHLORIDE | A208972 | EPIC PHARMA LLC
No patent or exclusivity listings for this strength.
Epic Pharma received FDA approval for Buspirone Hydrochloride under application 208972, supplement 007.
New: New record
Epic Pharma's buspirone hydrochloride (NDA 208972) therapeutic equivalence code changed from BX to AB, indicating the product now meets bioequivalence standards for generic substitution.
Old: BX
New: AB
Epic Pharma's buspirone hydrochloride product (NDA 208972) changed therapeutic equivalence code from BX to AB, indicating the FDA now considers it therapeutically equivalent to the reference-listed drug.
Old: BX
New: AB
Epic Pharma's Buspirone Hydrochloride (NADA 208972) therapeutic equivalence code changed from BX to AB, indicating the FDA now considers it therapeutically equivalent to reference-listed drug products.
Old: BX
New: AB
Epic Pharma LLC received FDA approval for a new Buspirone Hydrochloride product (NDA 208972, supplement 006).
New: New record
Epic Pharma's Buspirone Hydrochloride (NDA 208972, supplement 003) received an AB therapeutic equivalence rating, upgrading from its previous BX designation and establishing generic substitutability.
Old: BX
New: AB
Epic Pharma's Buspirone HCl (NDA 208972) received a therapeutic equivalence upgrade from BX to AB, indicating the product now meets standards for generic substitution.
Old: BX
New: AB