Orange Book product · Generic (ANDA)
MITIGO
MORPHINE SULFATE
At a glance
Jul 16, 2018
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 16, 2018
8 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MORPHINE SULFATE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 204393
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MORPHINE SULFATE
- 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 202515 · HOSPIRA INC
- 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
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.
