Orange Book product · Generic (ANDA)
CROMOLYN SODIUM
CROMOLYN SODIUM
At a glance
Oct 16, 2017
Approved
Generic (ANDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 2017
8 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CROMOLYN SODIUM
Strength
10MG/ML
Dosage form
SOLUTION
Route
INHALATION
TE code
AN
Application
ANDA 209453
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CROMOLYN SODIUM
- 1997NASALCROMBrand (NDA)
NDA 020463 · BLACKSMITH BRANDS
- 1996GASTROCROMBrand (NDA)
NDA 020479 · VIATRIS SPECIALTY
- 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
- 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.
