Orange Book product · Brand (NDA)
NYMALIZE
NIMODIPINE
At a glance
May 10, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 10, 2013
13 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
NIMODIPINE
Strength
3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 203340
Product number
001
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.
- 1988NIMOTOPBrand (NDA)
NDA 018869 · BAYER PHARMS
- 2025NIMODIPINEGeneric (ANDA)
ANDA 213409 · ALKEM LABS LTD
- 2024NIMODIPINEGeneric (ANDA)
ANDA 216937 · ANNORA PHARMA
- 2015NIMODIPINEGeneric (ANDA)
ANDA 201832 · SOFGEN PHARMS
- 2014NIMODIPINEGeneric (ANDA)
ANDA 090103 · THEPHARMANETWORK LLC
- 2008NIMODIPINEGeneric (ANDA)
ANDA 076740 · BIONPHARMA
- 2007NIMODIPINEGeneric (ANDA)
ANDA 077811 · HERITAGE
- 2007NIMODIPINEGeneric (ANDA)
ANDA 077067 · SUN PHARM INDS INC
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.
