LACOSAMIDE
MACLEODS PHARMS · LACOSAMIDE
Open FDA's page for this record- Application number
- ANDA208466
- Sponsor name
- MACLEODS PHARMS
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20240524
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- LACOSAMIDE
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- LACOSAMIDE
- Strength
- 50MG
- Product number
- 004
- Reference drug
- No
- Brand name
- LACOSAMIDE
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- LACOSAMIDE
- Strength
- 200MG
- Product number
- 002
- Reference drug
- No
- Brand name
- LACOSAMIDE
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- LACOSAMIDE
- Strength
- 100MG
- Product number
- 003
- Reference drug
- No
- Brand name
- LACOSAMIDE
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- LACOSAMIDE
- Strength
- 150MG
- Harmonized identifiers (openFDA)
- Application number
- ANDA208466
- Brand name
- LACOSAMIDE
- Generic name
- LACOSAMIDE
- Manufacturer name
- Macleods Pharmaceuticals Limited
- Product NDC
- 33342-302, 33342-303, 33342-304, 33342-305
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LACOSAMIDE
- RxCUI
- 809987, 809992, 809996, 810000
- SPL ID
- 035d85e5-8688-4390-bd55-74baa91c0e9d
- SPL set ID
- 035d85e5-8688-4390-bd55-74baa91c0e9d
- Package NDC
- 33342-302-09, 33342-302-11, 33342-303-09, 33342-303-11, 33342-304-09, 33342-304-11, 33342-305-09, 33342-305-11
- Nui
- N0000008486
- Pharm class pe
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- UNII
- 563KS2PQY5