DAPAGLIFLOZIN
MSN · DAPAGLIFLOZIN
Open FDA's page for this record- Application number
- ANDA211478
- Sponsor name
- MSN
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20260406
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Application docs
- ID
- 66715
- Url
- http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211478Orig1s000TA_ltr.pdf
- Date
- 20210310
- 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
- ANDA211478
- Brand name
- DAPAGLIFLOZIN
- Generic name
- DAPAGLIFLOZIN
- Manufacturer name
- AvKARE, Novadoz Pharmaceuticals LLC
- Product NDC
- 73190-072, 73190-073, 72205-432, 72205-433
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- DAPAGLIFLOZIN
- RxCUI
- 1488569, 1488574
- SPL ID
- 52cd45bb-5b41-152f-e063-6394a90abf5e, 7f52c2d6-0201-4a51-bfbf-b58460fd7edd
- SPL set ID
- 52a778e7-6044-2049-e063-6294a90aa0b7, 107b4d25-4764-42b7-80e3-9aaff20865ed
- Package NDC
- 73190-072-30, 73190-072-90, 73190-073-30, 73190-073-90, 72205-432-01, 72205-432-03, 72205-432-02, 72205-433-01, 72205-433-03, 72205-433-02
- Nui
- N0000187059, N0000187058
- Pharm class epc
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Pharm class moa
- Sodium-Glucose Transporter 2 Inhibitors [MoA]
- UNII
- 1ULL0QJ8UC