APO-CROMOLYN STERULES DIN 02231431
Health Canada record
| Active ingredient(s) | CROMOLYN SODIUM 1 % |
|---|---|
| Dosage form | Solution |
| Route | Inhalation |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R03BC01 CROMOGLICIC ACID |
| Original market date | 18-Jun-1998 |
| Current status date | 04-May-2019 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CROMOLYN SODIUM
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02279967 | ANTI-ALLERGY EYE DROPS | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Solution | CROMOLYN SODIUM 2 % | Approved |
| 02009277 | CROMOLYN EYE DROPS | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Solution | CROMOLYN SODIUM 2 % | Marketed |
| 02570807 | LUPIN-SODIUM CROMOGLICATE | LUPIN PHARMA CANADA LIMITED | Capsule | CROMOLYN SODIUM 100 MG | Approved |
| 00500895 | NALCROM | LUPIN PHARMA CANADA LIMITED | Capsule | CROMOLYN SODIUM 100 MG | Marketed |
| 02302721 | ALLERGAN EYE ITCH RELIEF | ALLERGAN INC | Solution | CROMOLYN SODIUM 2 % | Cancelled Pre Market |
| 02231390 | APO-CROMOLYN NASAL SPRAY | APOTEX INC | Spray | CROMOLYN SODIUM 2 % | Dormant |
| 02219468 | GEN-CROMOGLYCATE STERINEBS - LIQ INH 1% | GENPHARM ULC | Liquid | CROMOLYN SODIUM 1 % | Cancelled Post Market |
| 02231326 | GEN-CROMOLYN NASAL SPRAY | GENPHARM ULC | Solution; Metered-Dose Aerosol | CROMOLYN SODIUM 2 % | Cancelled Post Market |
| 00555649 | INTAL INHALER | SANOFI-AVENTIS CANADA INC | Metered-Dose Aerosol | CROMOLYN SODIUM 1 MG | Cancelled Post Market |
| 00534609 | INTAL NEBULIZER 1% | AVENTIS PHARMA INC | Solution | CROMOLYN SODIUM 1 % | Cancelled Post Market |
| 00261238 | INTAL SPINCAPS 20MG | AVENTIS PHARMA INC | Powder | CROMOLYN SODIUM 20 MG | Cancelled Post Market |
| 00638641 | INTAL SYNCRONER | AVENTIS PHARMA INC | Metered-Dose Aerosol | CROMOLYN SODIUM 1 MG | Cancelled Post Market |
| 02049082 | NOVO-CROMOLYN NEBULIZER SOLUTION 1% | NOVOPHARM LIMITED | Solution | CROMOLYN SODIUM 1 % | Cancelled Post Market |
| 02231351 | NU-CROMOLYN | NU-PHARM INC | Spray; Liquid | CROMOLYN SODIUM 2 % | Cancelled (Unreturned Annual) |
| 02231671 | NU-CROMOLYN PLASTIC AMPULES | NU-PHARM INC | Solution | CROMOLYN SODIUM 10 MG | Cancelled Post Market |
| 02230621 | OPTICROM | ALLERGAN INC | Solution | CROMOLYN SODIUM 2 % | Cancelled Post Market |
| 00394300 | OPTICROM LIQ 2% | RHONE-POULENC RORER CANADA INC. | Liquid | CROMOLYN SODIUM 2 % | Cancelled Post Market |
| 02046113 | PMS-SODIUM CROMOGLYCATE | PHARMASCIENCE INC | Solution | CROMOLYN SODIUM 1 % | Cancelled Post Market |
| 01950541 | RHINARIS-CS ANTI-ALLERGIC NASAL MIST | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Spray (Metered-Dose) | CROMOLYN SODIUM 2 % | Dormant |
| 00605255 | RYNACROM SOLUTION 2% | RHONE-POULENC RORER CANADA INC. | Metered-Dose Aerosol | CROMOLYN SODIUM 2 % | Cancelled Post Market |
| 02239657 | SOLU-CROM | SABEX INC | Liquid | CROMOLYN SODIUM 2 % | Cancelled Post Market |
| 00803561 | VISTACROM EYE OINTMENT 4% | ALLERGAN INC | Ointment | CROMOLYN SODIUM 40 MG | Cancelled Post Market |
| 00749478 | VISTACROM LIQ 2% | ALLERGAN INC | Liquid | CROMOLYN SODIUM 2 % | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 3689 | 1997-06-16 | Abbreviated New Drug Submission (ANDS) |
International API supply for CROMOLYN SODIUM
4 active FDA Drug Master Files.
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