FDA Orange Book · active-ingredient family
Cromolyn sodium
Cromolyn sodium is approved as 7 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NASALCROM · NDA 020463
7
Brand (NDA)
24
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered, capsule, concentrate, solution, solution/drops, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NASALCROMRLD | BLACKSMITH BRANDS | NDA 020463 | — | Jan 03, 1997 | |
| GASTROCROMRLD | VIATRIS SPECIALTY | NDA 020479 | AA | Feb 29, 1996 | |
| OPTICROMRLD | ALLERGAN | NDA 018155 | — | Oct 03, 1984 | |
| INTALRLD | KING PHARMS LLC | NDA 018596 | — | May 28, 1982 | |
| INTALRLD | SANOFI AVENTIS US | NDA 016990 | — | Approved Prior to Jan 1, 1982 | |
| GASTROCROM | UCB INC | NDA 019188 | — | Dec 22, 1989 | |
| INTAL | KING PHARMS LLC | NDA 018887 | — | Dec 05, 1985 |
Generic (ANDA) products (24)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CROMOLYN SODIUM | MICRO LABS | ANDA 213658 | AN | Apr 29, 2022 | |
| CROMOLYN SODIUM | AILEX PHARMS LLC | ANDA 209264 | AA | Oct 16, 2017 | |
| CROMOLYN SODIUM | AILEX PHARMS LLC | ANDA 209453 | AN | Oct 16, 2017 | |
| CROMOLYN SODIUM | MICRO LABS LTD INDIA | ANDA 202745 | AA | Apr 04, 2013 | |
| CROMOLYN SODIUM | RISING | ANDA 202583 | AA | Oct 27, 2011 | |
| CROMOLYN SODIUM | GENERA PHARMS | ANDA 090954 | — | Dec 18, 2009 | |
| CROMOLYN SODIUM | HH AND P | ANDA 077976 | — | Sep 07, 2007 | |
| CROMOLYN SODIUM | WATSON LABS | ANDA 076469 | — | Jun 17, 2005 | |
| CROMOLYN SODIUM | HIKMA | ANDA 075333 | — | Apr 30, 2002 | |
| CROMOLYN SODIUM | PERRIGO | ANDA 075427 | — | Dec 12, 2001 | |
| CROMOLYN SODIUM | ACTAVIS MID ATLANTIC | ANDA 074800 | — | Jul 26, 2001 | |
| CROMOLYN SODIUM | BAUSCH AND LOMB | ANDA 075702 | — | Jul 03, 2001 | |
| CROMOLYN SODIUM | APOTEX INC | ANDA 075615 | — | Jan 26, 2001 | |
| CROMOLYN SODIUM | BAUSCH | ANDA 075585 | — | Dec 21, 2000 | |
| CROMOLYN SODIUM | FERA PHARMS LLC | ANDA 075437 | AN | Apr 21, 2000 | |
| CROMOLYN SODIUM | TEVA PHARMS | ANDA 075271 | AN | Jan 18, 2000 | |
| CROMOLYN SODIUM | WOCKHARDT BIO AG | ANDA 075346 | AN | Oct 25, 1999 | |
| CROMOLYN SODIUM | ROXANE | ANDA 075175 | — | Sep 30, 1999 | |
| CROMOLYN SODIUM | ACTAVIS MID ATLANTIC | ANDA 075067 | — | Jul 19, 1999 | |
| CROMOLYN SODIUM | SANDOZ | ANDA 075282 | — | Jun 16, 1999 | |
| CROMOPTIC | KING PHARMS | ANDA 075088 | — | Apr 27, 1999 | |
| CROMOLYN SODIUM | SCIEGEN PHARMS | ANDA 074706 | — | Apr 29, 1998 | |
| CROLOM | BAUSCH AND LOMB | ANDA 074443 | — | Jan 30, 1995 | |
| CROMOLYN SODIUM | EUGIA PHARMA | ANDA 074209 | — | Apr 26, 1994 |
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.
Cromolyn sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
