Orange Book product · Brand (NDA)
GASTROCROM
CROMOLYN SODIUM
At a glance
Feb 29, 1996
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 29, 1996
30 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CROMOLYN SODIUM
Strength
100MG/5ML
Dosage form
CONCENTRATE
Route
ORAL
TE code
AA
Application
NDA 020479
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.
- 1997NASALCROMBrand (NDA)
NDA 020463 · BLACKSMITH BRANDS
- 1989GASTROCROMBrand (NDA)
NDA 019188 · UCB INC
- 1985INTALBrand (NDA)
NDA 018887 · KING PHARMS LLC
- 1984OPTICROMBrand (NDA)
NDA 018155 · ALLERGAN
- 1982INTALBrand (NDA)
NDA 018596 · KING PHARMS LLC
- —INTALBrand (NDA)
NDA 016990 · SANOFI AVENTIS US
- 2022CROMOLYN SODIUMGeneric (ANDA)
ANDA 213658 · MICRO LABS
- 2017CROMOLYN SODIUMGeneric (ANDA)
ANDA 209264 · AILEX PHARMS LLC
- 2017CROMOLYN SODIUMGeneric (ANDA)
ANDA 209453 · AILEX PHARMS LLC
- 2013CROMOLYN SODIUMGeneric (ANDA)
ANDA 202745 · MICRO LABS LTD INDIA
- 2011CROMOLYN SODIUMGeneric (ANDA)
ANDA 202583 · RISING
- 2009CROMOLYN SODIUMGeneric (ANDA)
ANDA 090954 · GENERA PHARMS
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.
