Orange Book product · Generic (ANDA)
TERBUTALINE SULFATE
TERBUTALINE SULFATE
At a glance
May 26, 2004
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 2004
22 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
TERBUTALINE SULFATE
Strength
1MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 076887
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
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
- 2009TERBUTALINE SULFATEGeneric (ANDA)
ANDA 078630 · HIKMA FARMACEUTICA
- 2008TERBUTALINE SULFATEGeneric (ANDA)
ANDA 078151 · EPIC PHARMA LLC
- 2005TERBUTALINE SULFATEGeneric (ANDA)
ANDA 077152 · LANNETT CO INC
- 2004TERBUTALINE SULFATEGeneric (ANDA)
ANDA 076853 · DR REDDYS
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.
