Orange Book product · Generic (ANDA)
CROMOLYN SODIUM
CROMOLYN SODIUM
At a glance
Apr 21, 2000
Approved
Generic (ANDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 21, 2000
26 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CROMOLYN SODIUM
Strength
10MG/ML
Dosage form
SOLUTION
Route
INHALATION
TE code
AN
Application
ANDA 075437
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
- 2017CROMOLYN SODIUMGeneric (ANDA)
ANDA 209453 · AILEX PHARMS LLC
- 2013CROMOLYN SODIUMGeneric (ANDA)
ANDA 202745 · MICRO LABS LTD INDIA
- 2011CROMOLYN SODIUMGeneric (ANDA)
ANDA 202583 · RISING
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.
