Orange Book product · Brand (NDA)
INTAL
CROMOLYN SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CROMOLYN SODIUM
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
INHALATION
TE code
Not listed
Application
NDA 016990
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 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
- 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.
