AZACITIDINE
MSN LABS PVT LTD · AZACITIDINE
Open FDA's page for this record- Application number
- ANDA212580
- Sponsor name
- MSN LABS PVT LTD
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20240516
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- AZACITIDINE
- Reference standard
- No
- Dosage form
- POWDER
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing status
- Prescription
- Te code
- AP
- Active ingredients
- Name
- AZACITIDINE
- Strength
- 100MG/VIAL
- Harmonized identifiers (openFDA)
- Application number
- ANDA212580
- Brand name
- AZACITIDINE
- Generic name
- AZACITIDINE
- Manufacturer name
- Sandoz Inc, MSN LABORATORIES PRIVATE LIMITED, Civica, Inc.
- Product NDC
- 0781-3491, 69539-112, 72572-020
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Substance name
- AZACITIDINE
- RxCUI
- 485246
- SPL ID
- bf6cb4b7-d4ec-4124-862c-aaa6a32da511, 149556cf-d002-4d8b-875b-062561da3f44, e2e6729f-6e81-476f-af63-82c094d4f6ee
- SPL set ID
- 7f89fcbd-d3f4-4112-8733-69baea41255e, d24f1fc5-17c6-4e0c-b852-72692e835cff, 2d15b3ec-ed08-48c6-a400-34e55974afad
- Package NDC
- 0781-3491-94, 69539-112-01, 72572-020-01
- Nui
- N0000000233, N0000175595
- Pharm class moa
- Nucleic Acid Synthesis Inhibitors [MoA]
- Pharm class epc
- Nucleoside Metabolic Inhibitor [EPC]
- UNII
- M801H13NRU