Orange Book product · Brand (NDA)
ARAMINE
METARAMINOL BITARTRATE
At a glance
Dec 22, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 1987
39 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
METARAMINOL BITARTRATE
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 009509
Product number
002
Marketing status
DISCN
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.
- 2021METARAMINOL BITARTRATEGeneric (ANDA)
ANDA 211304 · AZURITY
- —METARAMINOL BITARTRATEGeneric (ANDA)
ANDA 080431 · ABRAXIS PHARM
- —METARAMINOL BITARTRATEGeneric (ANDA)
ANDA 083363 · ELKINS SINN
- —METARAMINOL BITARTRATEGeneric (ANDA)
ANDA 080722 · FRESENIUS KABI USA
- —METARAMINOL BITARTRATEGeneric (ANDA)
ANDA 086418 · GD SEARLE LLC
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.
