Orange Book product · Brand (NDA)
REMERON SOLTAB
MIRTAZAPINE
At a glance
Jan 12, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 12, 2001
25 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
MIRTAZAPINE
Strength
15MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
AB
Application
NDA 021208
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1996REMERONBrand (NDA)
NDA 020415 · ORGANON
- 2026MIRTAZAPINEGeneric (ANDA)
ANDA 220104 · MICRO LABS
- 2026MIRTAZAPINEGeneric (ANDA)
ANDA 219919 · NOVITIUM PHARMA
- 2025MIRTAZAPINEGeneric (ANDA)
ANDA 219721 · ANNORA PHARMA
- 2023MIRTAZAPINEGeneric (ANDA)
ANDA 216751 · PRASCO
- 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.
