Orange Book product · Brand (NDA)
MORPHINE SULFATE
MORPHINE SULFATE
At a glance
Apr 29, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 2021
5 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
MORPHINE SULFATE
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 202515
Product number
006
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.
- 2017ARYMO ERBrand (NDA)
NDA 208603 · ZYLA
- 2015MORPHABOND ERBrand (NDA)
NDA 206544 · OHEMO LIFE
- 2013MORPHINE SULFATEBrand (NDA)
NDA 204223 · FRESENIUS KABI USA
- 2011MORPHINE SULFATEBrand (NDA)
NDA 201517 · CHARTWELL MOLECULAR
- 2008MORPHINE SULFATEBrand (NDA)
NDA 022195 · HIKMA
- 2007KADIANBrand (NDA)
NDA 020616 · ALLERGAN
- 2004DEPODURBrand (NDA)
NDA 021671 · PACIRA PHARMS INC
- 2002AVINZABrand (NDA)
NDA 021260 · KING PHARMS LLC
- 1996MORPHINE SULFATEBrand (NDA)
NDA 020631 · SPECGX LLC
- 1992MORPHINE SULFATEBrand (NDA)
NDA 019917 · ICU MEDICAL INC
- 1992MORPHINE SULFATEBrand (NDA)
NDA 019916 · ICU MEDICAL INC
- 1990MORPHINE SULFATE (AUTOINJECTOR)Brand (NDA)
NDA 019999 · MERIDIAN MEDCL TECHN
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.
