DAPAGLIFLOZIN
MACLEODS PHARMS · DAPAGLIFLOZIN
Open FDA's page for this record- Application number
- ANDA211506
- Sponsor name
- MACLEODS PHARMS
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20260406
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 002
- Reference drug
- No
- Brand name
- DAPAGLIFLOZIN
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- DAPAGLIFLOZIN
- Strength
- 10MG
- Product number
- 001
- Reference drug
- No
- Brand name
- DAPAGLIFLOZIN
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- DAPAGLIFLOZIN
- Strength
- 5MG
- Harmonized identifiers (openFDA)
- Application number
- ANDA211506
- Brand name
- DAPAGLIFLOZIN
- Generic name
- DAPAGLIFLOZIN
- Manufacturer name
- Macleods Pharmaceuticals Limited
- Product NDC
- 33342-585, 33342-586
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- DAPAGLIFLOZIN
- RxCUI
- 1488569, 1488574
- SPL ID
- 31e8764a-d64a-4282-8072-9fd6b7c24ea4
- SPL set ID
- 91373924-66dc-4277-aaf2-8536e81a0e4d
- Package NDC
- 33342-585-07, 33342-585-10, 33342-585-66, 33342-585-12, 33342-586-07, 33342-586-10, 33342-586-66, 33342-586-56
- Nui
- N0000187059, N0000187058
- Pharm class epc
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Pharm class moa
- Sodium-Glucose Transporter 2 Inhibitors [MoA]
- UNII
- 1ULL0QJ8UC