Orange Book product · Generic (ANDA)
TERBUTALINE SULFATE
TERBUTALINE SULFATE
At a glance
May 20, 2009
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 20, 2009
17 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
TERBUTALINE SULFATE
Strength
1MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 078630
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of TERBUTALINE SULFATE
- 1985BRICANYLBrand (NDA)
NDA 018000 · SANOFI AVENTIS US
- 1984BRETHAIREBrand (NDA)
NDA 018762 · NOVARTIS
- —BRETHINEBrand (NDA)
NDA 018571 · PHARMACARE
- —BRICANYLBrand (NDA)
NDA 017466 · SANOFI AVENTIS US
- —BRETHINEBrand (NDA)
NDA 017849 · ANI PHARMS
- —BRICANYLBrand (NDA)
NDA 017618 · SANOFI AVENTIS US
- 2020TERBUTALINE SULFATEGeneric (ANDA)
ANDA 211832 · TWI PHARMS
- 2013TERBUTALINE SULFATEGeneric (ANDA)
ANDA 200122 · AREVA PHARMS
- 2008TERBUTALINE SULFATEGeneric (ANDA)
ANDA 078151 · EPIC PHARMA LLC
- 2005TERBUTALINE SULFATEGeneric (ANDA)
ANDA 077152 · LANNETT CO INC
- 2004TERBUTALINE SULFATEGeneric (ANDA)
ANDA 076853 · DR REDDYS
- 2004TERBUTALINE SULFATEGeneric (ANDA)
ANDA 076887 · FRESENIUS KABI USA
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.
