LORATADINE SOFT GELATIN CAPSULES DIN 02493519
Health Canada record
| Active ingredient(s) | LORATADINE 10 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | NON-PRESCRIPTION DRUGS |
| Class | Human |
| ATC | R06AX13 LORATADINE |
| Original market date | |
| Current status date | 31-Oct-2019 |
| Source | Health Canada DPD |
Establishment licence of the holder
Catalent Ontario Limited — licence 3-002513, currently licensed, last inspection rating C (2025-08-18).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing LORATADINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02280159 | 24 HOUR ALLERGY REMEDY | VITA HEALTH PRODUCTS INC | Tablet | LORATADINE 10 MG | Marketed |
| 02375990 | ALLERGY REMEDY | APOTEX INC | Tablet | LORATADINE 10 MG | Marketed |
| 02390388 | ALLERTIN | APOTEX INC | Capsule | LORATADINE 10 MG | Marketed |
| 02243880 | APO-LORATADINE | APOTEX INC | Tablet | LORATADINE 10 MG | Marketed |
| 00782696 | CLARITIN ALLERGY | BAYER INC | Tablet | LORATADINE 10 MG | Marketed |
| 01945157 | CLARITIN ALLERGY + SINUS | BAYER INC | Tablet (Immediate- And Extended-Release) | LORATADINE 5 MG; PSEUDOEPHEDRINE SULFATE 120 MG | Marketed |
| 02241523 | CLARITIN KIDS | BAYER INC | Syrup | LORATADINE 5 MG | Marketed |
| 02508761 | CLARITIN KIDS RAPID DISSOLVE | BAYER INC | Tablet (Orally-Disintegrating) | LORATADINE 5 MG | Marketed |
| 02404494 | CLARITIN LIQUID CAPSULES | BAYER INC | Capsule | LORATADINE 10 MG | Marketed |
| 02237734 | CLARITIN RAPID DISSOLVE | BAYER INC | Tablet (Orally-Disintegrating) | LORATADINE 10 MG | Marketed |
| 02380226 | CLARITIN RAPID DISSOLVE | BAYER INC | Tablet (Orally-Disintegrating) | LORATADINE 5 MG | Approved |
| 02366444 | LORATADINE | APOTEX INC | Tablet | LORATADINE 10 MG | Marketed |
| 02379481 | LORATADINE SOFT GEL CAPSULES | APOTEX INC | Capsule | LORATADINE 10 MG | Marketed |
| 02251795 | TARO-LORATADINE | TARO PHARMACEUTICALS INC | Tablet | LORATADINE 10 MG | Approved |
| 02418959 | ALLERTIN | APOTEX INC | Tablet | LORATADINE 10 MG | Dormant |
| 02244691 | ALLERTIN TABLETS 10MG | VITA HEALTH PRODUCTS INC | Tablet | LORATADINE 10 MG | Cancelled Post Market |
| 01970399 | CHLOR-TRIPOLON ND SRT | SCHERING-PLOUGH CANADA INC | Tablet (Extended-Release) | LORATADINE 5 MG; PSEUDOEPHEDRINE SULFATE 120 MG | Cancelled Post Market |
| 02019973 | CLARITIN SYRUP 1MG/ML | SCHERING-PLOUGH CANADA INC | Syrup | LORATADINE 1 MG | Cancelled Post Market |
| 02244941 | LIBERATOR | SCHERING-PLOUGH CANADA INC | Tablet (Extended-Release) | LORATADINE 10 MG; PSEUDOEPHEDRINE SULFATE 240 MG | Cancelled Post Market |
| 02284669 | LORATADINE | MYLAN PHARMACEUTICALS ULC | Tablet | LORATADINE 10 MG | Cancelled Pre Market |
| 02244692 | LORATADINE TABLETS 10MG | VITA HEALTH PRODUCTS INC | Tablet | LORATADINE 10 MG | Cancelled Post Market |
| 02242957 | NOVO-LORATADINE | NOVOPHARM LIMITED | Tablet | LORATADINE 10 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 22842 | 2019-10-31 | New Drug Submission (NDS) |
International API supply for LORATADINE
7 valid EDQM Certificates of Suitability from 7 holders. 23 active FDA Drug Master Files.
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