Orange Book product · Brand (NDA)
BRETHINE
TERBUTALINE SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TERBUTALINE SULFATE
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 017849
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 1985BRICANYLBrand (NDA)
NDA 018000 · SANOFI AVENTIS US
- 1984BRETHAIREBrand (NDA)
NDA 018762 · NOVARTIS
- —BRETHINEBrand (NDA)
NDA 018571 · PHARMACARE
- —BRICANYLBrand (NDA)
NDA 017466 · SANOFI AVENTIS US
- —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
- 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.
