Orange Book product · Brand (NDA)
CARAFATE
SUCRALFATE
At a glance
Dec 16, 1993
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 16, 1993
33 yr ago
Today
Pharmaceutical detail
Active ingredient
SUCRALFATE
Strength
1GM/10ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 019183
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- —CARAFATEBrand (NDA)
NDA 018333 · ABBVIE
- 2026SUCRALFATEGeneric (ANDA)
ANDA 212141 · GLENMARK PHARMS LTD
- 2025SUCRALFATEGeneric (ANDA)
ANDA 211780 · PADAGIS US
- 2024SUCRALFATEGeneric (ANDA)
ANDA 217126 · COSETTE PHARMS NC
- 2024SUCRALFATEGeneric (ANDA)
ANDA 212769 · HIKMA
- 2024SUCRALFATEGeneric (ANDA)
ANDA 216474 · STRIDES PHARMA
- 2024SUCRALFATEGeneric (ANDA)
ANDA 216726 · ABON PHARMS LLC
- 2024SUCRALFATEGeneric (ANDA)
ANDA 213549 · PD PARTNERS
- 2023SUCRALFATEGeneric (ANDA)
ANDA 215705 · ZYDUS LIFESCIENCES
- 2022SUCRALFATEGeneric (ANDA)
ANDA 212913 · MYLAN
- 2022SUCRALFATEGeneric (ANDA)
ANDA 215576 · AMNEAL PHARMS
- 2022SUCRALFATEGeneric (ANDA)
ANDA 211884 · VISTAPHARM LLC
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.
