FENOFIBRATE (MICRONIZED)
CHARTWELL · FENOFIBRATE
Open FDA's page for this record- Application number
- ANDA211407
- Sponsor name
- CHARTWELL
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20240131
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 003
- Reference drug
- No
- Brand name
- FENOFIBRATE (MICRONIZED)
- Reference standard
- No
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- FENOFIBRATE
- Strength
- 200MG
- Product number
- 001
- Reference drug
- No
- Brand name
- FENOFIBRATE (MICRONIZED)
- Reference standard
- No
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- FENOFIBRATE
- Strength
- 67MG
- Product number
- 002
- Reference drug
- No
- Brand name
- FENOFIBRATE (MICRONIZED)
- Reference standard
- No
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- FENOFIBRATE
- Strength
- 134MG
- Harmonized identifiers (openFDA)
- Application number
- ANDA211407
- Brand name
- FENOFIBRATE
- Generic name
- FENOFIBRATE
- Manufacturer name
- Chartwell RX, LLC.
- Product NDC
- 62135-893, 62135-894, 62135-899
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- FENOFIBRATE
- RxCUI
- 200311, 310288, 310289
- SPL ID
- 459be037-d59a-9ee0-e063-6394a90a3b5e
- SPL set ID
- 2d0cfddc-ace3-4187-8d94-d760d23d20b6
- Package NDC
- 62135-893-90, 62135-894-90, 62135-899-90
- Nui
- N0000175596, N0000175375, M0543661
- Pharm class epc
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- Pharm class moa
- Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
- Pharm class cs
- Fibric Acids [CS]
- UNII
- U202363UOS