DAPAGLIFLOZIN
SANDOZ · DAPAGLIFLOZIN
Open FDA's page for this record- Application number
- ANDA211312
- Sponsor name
- SANDOZ
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20260406
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Application docs
- ID
- 59597
- Url
- http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211312Orig1s000TAltr.pdf
- Date
- 20190806
- Type
- Letter
- Products
- 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
- 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
- Harmonized identifiers (openFDA)
- Application number
- ANDA211312
- Brand name
- DAPAGLIFLOZIN
- Generic name
- DAPAGLIFLOZIN
- Manufacturer name
- Sandoz Inc
- Product NDC
- 0781-5985, 0781-5990
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- DAPAGLIFLOZIN
- RxCUI
- 1488569, 1488574
- SPL ID
- d525993f-e65e-4258-a8a2-e4f8c344d74d
- SPL set ID
- 8296f538-4c23-4d6c-be53-8005b83c24b7
- Package NDC
- 0781-5985-31, 0781-5985-01, 0781-5985-05, 0781-5985-10, 0781-5990-31, 0781-5990-01, 0781-5990-05, 0781-5990-10
- Nui
- N0000187059, N0000187058
- Pharm class epc
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Pharm class moa
- Sodium-Glucose Transporter 2 Inhibitors [MoA]
- UNII
- 1ULL0QJ8UC