Orange Book product · Generic (ANDA)
TERBUTALINE SULFATE
TERBUTALINE SULFATE
At a glance
Jun 26, 2001
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 2001
25 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
TERBUTALINE SULFATE
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 075877
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.
