AG-LEVOCARB DIN 02551365
Health Canada record
| Active ingredient(s) | LEVODOPA 100 MG; CARBIDOPA 25 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N04BA02 LEVODOPA AND DECARBOXYLASE INHIBITOR |
| Original market date | 17-Dec-2024 |
| Current status date | 17-Dec-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Angita Pharma Inc. — licence 101870, currently licensed, last inspection rating C (2025-01-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing LEVODOPA
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02272873 | AA-LEVOCARB CR | AA PHARMA INC | Tablet (Extended-Release) | LEVODOPA 100 MG; CARBIDOPA 25 MG | Marketed |
| 02245211 | AA-LEVOCARB CR | AA PHARMA INC | Tablet (Extended-Release) | LEVODOPA 200 MG; CARBIDOPA 50 MG | Marketed |
| 02551373 | AG-LEVOCARB | ANGITA PHARMA INC. | Tablet | LEVODOPA 250 MG; CARBIDOPA 25 MG | Approved |
| 02551357 | AG-LEVOCARB | ANGITA PHARMA INC. | Tablet | LEVODOPA 100 MG; CARBIDOPA 10 MG | Approved |
| 02531607 | AURO-LEVOCARB | AURO PHARMA INC | Tablet | LEVODOPA 100 MG; CARBIDOPA 25 MG | Marketed |
| 02531593 | AURO-LEVOCARB | AURO PHARMA INC | Tablet | LEVODOPA 100 MG; CARBIDOPA 10 MG | Marketed |
| 02531615 | AURO-LEVOCARB | AURO PHARMA INC | Tablet | LEVODOPA 250 MG; CARBIDOPA 25 MG | Marketed |
| 02292165 | DUODOPA | ABBVIE CORPORATION | Gel | LEVODOPA 20 MG; CARBIDOPA (CARBIDOPA MONOHYDRATE) 5 MG | Marketed |
| 02517884 | LEVODOPA, CARBIDOPA AND ENTACAPONE TABLETS | STRIDES PHARMA CANADA INC | Tablet | LEVODOPA 150 MG; CARBIDOPA 37.5 MG; ENTACAPONE 200 MG | Approved |
| 02517876 | LEVODOPA, CARBIDOPA AND ENTACAPONE TABLETS | STRIDES PHARMA CANADA INC | Tablet | LEVODOPA 50 MG; CARBIDOPA 12.5 MG; ENTACAPONE 200 MG | Approved |
| 02457954 | MINT-LEVOCARB | MINT PHARMACEUTICALS INC | Tablet | LEVODOPA 100 MG; CARBIDOPA 10 MG | Marketed |
| 02457962 | MINT-LEVOCARB | MINT PHARMACEUTICALS INC | Tablet | LEVODOPA 100 MG; CARBIDOPA 25 MG | Marketed |
| 00386464 | PROLOPA CAP 100-25 | HOFFMANN-LA ROCHE LIMITED | Capsule | LEVODOPA 100 MG; BENSERAZIDE (BENSERAZIDE HYDROCHLORIDE) 25 MG | Marketed |
| 00386472 | PROLOPA CAP 200-50 | HOFFMANN-LA ROCHE LIMITED | Capsule | LEVODOPA 200 MG; BENSERAZIDE (BENSERAZIDE HYDROCHLORIDE) 50 MG | Marketed |
| 00522597 | PROLOPA CAP 50-12.5 | HOFFMANN-LA ROCHE LIMITED | Capsule | LEVODOPA 50 MG; BENSERAZIDE (BENSERAZIDE HYDROCHLORIDE) 12.5 MG | Marketed |
| 02498863 | SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 100 MG; CARBIDOPA 25 MG; ENTACAPONE 200 MG | Approved |
| 02498855 | SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 50 MG; CARBIDOPA 12.5 MG; ENTACAPONE 200 MG | Approved |
| 02498871 | SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 125 MG; CARBIDOPA 31.25 MG; ENTACAPONE 200 MG | Approved |
| 02498901 | SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 150 MG; CARBIDOPA 37.5 MG; ENTACAPONE 200 MG | Approved |
| 02498898 | SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 75 MG; CARBIDOPA 18.75 MG; ENTACAPONE 200 MG | Approved |
| 02337835 | STALEVO | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 125 MG; CARBIDOPA 31.25 MG; ENTACAPONE 200 MG | Marketed |
| 02305933 | STALEVO | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 50 MG; CARBIDOPA 12.5 MG; ENTACAPONE 200 MG | Marketed |
| 02305941 | STALEVO | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 100 MG; CARBIDOPA 25 MG; ENTACAPONE 200 MG | Marketed |
| 02305968 | STALEVO | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 150 MG; CARBIDOPA 37.5 MG; ENTACAPONE 200 MG | Marketed |
| 02337827 | STALEVO | SANDOZ CANADA INCORPORATED | Tablet | LEVODOPA 75 MG; CARBIDOPA 18.75 MG; ENTACAPONE 200 MG | Marketed |
| 02421496 | LEVODOPA-CARBIDOPA CR | PHARMASCIENCE INC | Tablet (Extended-Release) | LEVODOPA 200 MG; CARBIDOPA 50 MG | Dormant |
| 02421488 | LEVODOPA-CARBIDOPA CR | PHARMASCIENCE INC | Tablet (Extended-Release) | LEVODOPA 100 MG; CARBIDOPA 25 MG | Dormant |
| 02457970 | MINT-LEVOCARB | MINT PHARMACEUTICALS INC | Tablet | LEVODOPA 250 MG; CARBIDOPA 25 MG | Dormant |
| 02311178 | PRO-LEVOCARB - 100/25 | PRO DOC LIMITEE | Tablet | LEVODOPA 100 MG; CARBIDOPA 25 MG | Cancelled Post Market |
| 02126184 | RATIO-LEVODOPA/CARBIDOPA | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | LEVODOPA 250 MG; CARBIDOPA 25 MG | Cancelled Post Market |
| 02126176 | RATIO-LEVODOPA/CARBIDOPA | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | LEVODOPA 100 MG; CARBIDOPA 10 MG | Cancelled Post Market |
| 02126168 | RATIO-LEVODOPA/CARBIDOPA | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | LEVODOPA 100 MG; CARBIDOPA 25 MG | Cancelled Post Market |
| 00355658 | SINEMET 100/10 | MERCK CANADA INC | Tablet | LEVODOPA 100 MG; CARBIDOPA 10 MG | Cancelled Post Market |
| 02028786 | SINEMET CR 100/25 | MERCK CANADA INC | Tablet (Extended-Release) | LEVODOPA 100 MG; CARBIDOPA 25 MG | Cancelled Post Market |
| 00870935 | SINEMET CR 200/50 | MERCK CANADA INC | Tablet (Extended-Release) | LEVODOPA 200 MG; CARBIDOPA 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 33910 | 2024-08-30 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement between two manufacturers |
International API supply for LEVODOPA
10 valid EDQM Certificates of Suitability from 10 holders. 13 active FDA Drug Master Files.
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