Orange Book product · Brand (NDA)
GASTROCROM
CROMOLYN SODIUM
At a glance
Dec 22, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 1989
37 yr ago
Today
Pharmaceutical detail
Active ingredient
CROMOLYN SODIUM
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 019188
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1997NASALCROMBrand (NDA)
NDA 020463 · BLACKSMITH BRANDS
- 1996GASTROCROMBrand (NDA)
NDA 020479 · VIATRIS SPECIALTY
- 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.
