Orange Book product · Generic (ANDA)
CLARITHROMYCIN
CLARITHROMYCIN
At a glance
Sep 04, 2007
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 04, 2007
19 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CLARITHROMYCIN
Strength
125MG/5ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 065283
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CLARITHROMYCIN
- 2000BIAXIN XLBrand (NDA)
NDA 050775 · ABBVIE
- 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 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.
