Data updated: May 26, 2026
INTAL (cromolyn sodium)
Respiratory
Approved 1982-05-28
2
Indications
--
Phase 3 Trials
1
Priority Reviews
43
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1982-05-28
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED, SOLUTION, CAPSULE
INTAL Approval History
1983
1984
1985
1986
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1993
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1995
1996
1997
1998
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2002
2003
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2025
2026
Original
New Indication
New Form
Label Update
32 FDA actions from 1982 to 2004
Mar 2002 SUPPL Priority
Mfg · Manufacturing (CMC)
Jul 1997 SUPPL
Label · Labeling
May 1997 SUPPL
Label
Mar 1996 SUPPL
Label
Feb 1996 SUPPL Priority
Mfg
Dec 1995 SUPPL
Mfg
Dec 1995 SUPPL
Mfg
Dec 1995 SUPPL Priority
Mfg
Oct 1993 SUPPL
Label
Aug 1993 SUPPL
Label
Mar 1993 SUPPL Priority
Mfg
Apr 1988 SUPPL
Mfg
Nov 1986 SUPPL Priority
Mfg
Aug 1986 SUPPL Priority
Mfg
Feb 1986 SUPPL Priority
Mfg
Jan 1986 SUPPL
Mfg
Dec 1985 ORIGINAL
New Form
Jan 1985 SUPPL
Label
Nov 1984 SUPPL Priority
Mfg
Sep 1984 SUPPL
Label
Aug 1984 SUPPL Priority
Mfg
Oct 1983 SUPPL
Label
Dec 1982 SUPPL
Label
May 1982 ORIGINAL Priority
New Form
What INTAL Treats
2 FDA approvalsOriginally approved for its first indication in 1982 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (May 1982) Priority
- • Approved indication (Dec 1985)
📋
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07526558 | 24-0990 | Ph 2 | not yet recruiting | Mast Cell Treatment in Post-tick Bite Illness (PTBI) |
| NCT05077917 | E21197 | Ph 3 | terminated | Cromolyn Sodium for Treatment of COVID-19 Pneumonia |
| NCT01933464 results posted | 130199 | Ph 1, Ph 2 | completed | An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema |
| NCT01841307 | 13-11080 | Ph 1 | terminated | Cromolyn Detection of Silent Aspiration |
| NCT02566252 | PUL-042-003 | Ph 1 | completed | Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042) |
| NCT00745199 | 4146 | Ph 2 | completed | Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INTAL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.