Orange Book product · Brand (NDA)
BIAXIN XL
CLARITHROMYCIN
At a glance
Mar 03, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 03, 2000
26 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CLARITHROMYCIN
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 050775
Product number
001
Marketing status
DISCN
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.
- 1993BIAXINBrand (NDA)
NDA 050698 · ABBVIE
- 1991BIAXINBrand (NDA)
NDA 050662 · ABBVIE
- 2022CLARITHROMYCINGeneric (ANDA)
ANDA 210459 · ALEMBIC
- 2019CLARITHROMYCINGeneric (ANDA)
ANDA 206714 · JUBILANT CADISTA
- 2018CLARITHROMYCINGeneric (ANDA)
ANDA 208987 · SUNSHINE
- 2016CLARITHROMYCINGeneric (ANDA)
ANDA 203243 · MPP PHARMA
- 2015CLARITHROMYCINGeneric (ANDA)
ANDA 203584 · HEC PHARM
- 2015CLARITHROMYCINGeneric (ANDA)
ANDA 202532 · LUPIN
- 2013CLARITHROMYCINGeneric (ANDA)
ANDA 202710 · NOVITIUM PHARMA
- 2012CLARITHROMYCINGeneric (ANDA)
ANDA 065489 · AUROBINDO
- 2007CLARITHROMYCINGeneric (ANDA)
ANDA 065283 · SANDOZ
- 2007CLARITHROMYCINGeneric (ANDA)
ANDA 065382 · SUN PHARM INDS LTD
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.
