Orange Book product · Brand (NDA)
PHOSLO GELCAPS
CALCIUM ACETATE
At a glance
Apr 02, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 02, 2001
25 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCIUM ACETATE
Strength
667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021160
Product number
003
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.
- 2011PHOSLYRABrand (NDA)
NDA 022581 · FRESENIUS MEDCL CARE
- 1990PHOSLOBrand (NDA)
NDA 019976 · FRESENIUS MEDCL CARE
- 2023CALCIUM ACETATEGeneric (ANDA)
ANDA 217205 · SQUARE PHARMS
- 2020CALCIUM ACETATEGeneric (ANDA)
ANDA 211038 · SUVEN PHARMS
- 2016CALCIUM ACETATEGeneric (ANDA)
ANDA 203298 · LOTUS PHARM CO LTD
- 2015CALCIUM ACETATEGeneric (ANDA)
ANDA 203179 · MPP PHARMA
- 2015CALCIUM ACETATEGeneric (ANDA)
ANDA 202127 · LUPIN
- 2015CALCIUM ACETATEGeneric (ANDA)
ANDA 202315 · HERITAGE PHARMS INC
- 2015CALCIUM ACETATEGeneric (ANDA)
ANDA 202885 · HERITAGE PHARMS INC
- 2014CALCIUM ACETATEGeneric (ANDA)
ANDA 201658 · AMNEAL PHARMS
- 2013CALCIUM ACETATEGeneric (ANDA)
ANDA 203135 · INVAGEN PHARMS
- 2013CALCIUM ACETATEGeneric (ANDA)
ANDA 202420 · CHARTWELL MOLECULAR
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.
