Orange Book product · Generic (ANDA)
MIRTAZAPINE
MIRTAZAPINE
At a glance
Jan 18, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 18, 2023
3 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
MIRTAZAPINE
Strength
7.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 216751
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MIRTAZAPINE
- 2001REMERON SOLTABBrand (NDA)
NDA 021208 · ORGANON USA ORGANON
- 1996REMERONBrand (NDA)
NDA 020415 · ORGANON
- 2026MIRTAZAPINEGeneric (ANDA)
ANDA 220104 · MICRO LABS
- 2026MIRTAZAPINEGeneric (ANDA)
ANDA 219919 · NOVITIUM PHARMA
- 2025MIRTAZAPINEGeneric (ANDA)
ANDA 219721 · ANNORA PHARMA
- 2017MIRTAZAPINEGeneric (ANDA)
ANDA 205798 · SQUARE PHARMS PLC
- 2011MIRTAZAPINEGeneric (ANDA)
ANDA 077959 · ACTAVIS ELIZABETH
- 2007MIRTAZAPINEGeneric (ANDA)
ANDA 077666 · APOTEX
- 2005MIRTAZAPINEGeneric (ANDA)
ANDA 077376 · AUROBINDO PHARMA
- 2005MIRTAZAPINEGeneric (ANDA)
ANDA 076689 · ACTAVIS ELIZABETH
- 2005MIRTAZAPINEGeneric (ANDA)
ANDA 076901 · IMPAX LABS INC
- 2004MIRTAZAPINEGeneric (ANDA)
ANDA 076921 · AUROBINDO
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
