FDA Orange Book · active-ingredient family
Cromolyn sodium
Cromolyn sodium: 7 brands, 24 generics; first approved May 28, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 24 ANDA applications approved.
Brands (NDA)
7
Generics (ANDA)
24
Listed patents
0
Presentations
31
Brand (NDA) products
Originator applications
- NASALCROMRLDBLACKSMITH BRANDSNDA 0204631997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5.2MG/SPRAY SPRAY, METERED NASAL Discontinued — - VIATRIS SPECIALTYNDA 0204791996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML CONCENTRATE ORAL Rx AA - OPTICROMRLDALLERGANNDA 0181551984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% SOLUTION/DROPS OPHTHALMIC Discontinued — - INTALRLDKING PHARMS LLCNDA 0185961982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Discontinued — - INTALRLDSANOFI AVENTIS USNDA 016990—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE INHALATION Discontinued — - UCB INCNDA 0191881989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - KING PHARMS LLCNDA 0188871985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.8MG/INH AEROSOL, METERED INHALATION Discontinued —
Generic (ANDA) products (24)
Abbreviated applications
- CROMOLYN SODIUMMICRO LABSANDA 2136582022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Rx AN - CROMOLYN SODIUMAILEX PHARMS LLCANDA 2092642017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML CONCENTRATE ORAL Rx AA - CROMOLYN SODIUMAILEX PHARMS LLCANDA 2094532017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Rx AN - CROMOLYN SODIUMMICRO LABS LTD INDIAANDA 2027452013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML CONCENTRATE ORAL Rx AA - CROMOLYN SODIUMRISINGANDA 2025832011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML CONCENTRATE ORAL Rx AA - CROMOLYN SODIUMGENERA PHARMSANDA 0909542009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML CONCENTRATE ORAL Discontinued — - CROMOLYN SODIUMHH AND PANDA 0779762007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5.2MG/SPRAY SPRAY, METERED NASAL Discontinued — - CROMOLYN SODIUMWATSON LABSANDA 0764692005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Discontinued — - CROMOLYN SODIUMHIKMAANDA 0753332002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Discontinued — - CROMOLYN SODIUMPERRIGOANDA 0754272001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5.2MG/SPRAY SPRAY, METERED NASAL Discontinued — - CROMOLYN SODIUMACTAVIS MID ATLANTICANDA 0748002001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5.2MG/SPRAY SPRAY, METERED NASAL Discontinued — - CROMOLYN SODIUMRSBAUSCH AND LOMBANDA 0757022001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5.2MG/SPRAY SPRAY, METERED NASAL OTC — - CROMOLYN SODIUMAPOTEX INCANDA 0756152001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% SOLUTION/DROPS OPHTHALMIC Discontinued — - CROMOLYN SODIUMBAUSCHANDA 0755852000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Discontinued — - CROMOLYN SODIUMFERA PHARMS LLCANDA 0754372000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Rx AN - CROMOLYN SODIUMRSTEVA PHARMSANDA 0752712000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Rx AN - CROMOLYN SODIUMWOCKHARDT BIO AGANDA 0753461999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Rx AN - CROMOLYN SODIUMROXANEANDA 0751751999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Discontinued — - CROMOLYN SODIUMACTAVIS MID ATLANTICANDA 0750671999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Discontinued — - CROMOLYN SODIUMRSSANDOZANDA 0752821999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% SOLUTION/DROPS OPHTHALMIC Rx — - KING PHARMSANDA 0750881999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% SOLUTION/DROPS OPHTHALMIC Discontinued — - CROMOLYN SODIUMSCIEGEN PHARMSANDA 0747061998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% SOLUTION/DROPS OPHTHALMIC Discontinued — - BAUSCH AND LOMBANDA 0744431995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% SOLUTION/DROPS OPHTHALMIC Discontinued — - CROMOLYN SODIUMEUGIA PHARMAANDA 0742091994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION INHALATION Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 11 mo ago
Most recent approval
4 yr 5 mo ago
Approvals span 1982–2022 across 31 FDA applications.
Brand (NDA) 723%
Generic (ANDA) 2477%
Cromolyn sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
