Orange Book product · Brand (NDA)
TOPROL-XL
METOPROLOL SUCCINATE
At a glance
Feb 05, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 05, 2001
25 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
METOPROLOL SUCCINATE
Strength
EQ 25MG TARTRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 019962
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2018KAPSPARGO SPRINKLEBrand (NDA)
NDA 210428 · SPIL
- 2026METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 214110 · ZHEJIANG JUTAI PHARM
- 2025METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 206980 · IPCA LABS LTD
- 2024METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 214004 · SUNSHINE
- 2023METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 209272 · LUPIN
- 2023METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 216509 · GRANULES
- 2023METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 216916 · GRANULES
- 2022METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 215637 · ACCORD HLTHCARE
- 2022METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 213854 · YICHANG HUMANWELL
- 2022METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 210597 · PRINSTON INC
- 2020METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 211143 · ALKEM LABS LTD
- 2020METOPROLOL SUCCINATEGeneric (ANDA)
ANDA 205541 · HETERO LABS LTD III
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.
