KETOCONAZOLE
ZYDUS LIFESCIENCES · KETOCONAZOLE
Open FDA's page for this record- Application number
- ANDA218559
- Sponsor name
- ZYDUS LIFESCIENCES
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20250307
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- KETOCONAZOLE
- Reference standard
- No
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- KETOCONAZOLE
- Strength
- 2%
- Harmonized identifiers (openFDA)
- Application number
- ANDA218559
- Brand name
- KETOCONAZOLE
- Generic name
- KETOCONAZOLE
- Manufacturer name
- Viona Pharmaceuticals Inc, Zydus Lifesciences Limited
- Product NDC
- 72578-156, 70771-1874
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Substance name
- KETOCONAZOLE
- RxCUI
- 106336
- SPL ID
- 122ec3a2-4c9a-4f27-8c82-643b968823e2, 9795147c-bca9-481c-b910-edee5bdd5f29
- SPL set ID
- a4bb3f4c-ad93-4d85-b8d0-54eaa62228fd, c004ee91-558a-450b-9e4e-d11ab9d28054
- Package NDC
- 72578-156-12, 70771-1874-7
- Nui
- N0000175487, M0002083, N0000182141, N0000190115, N0000185503
- Pharm class epc
- Azole Antifungal [EPC]
- Pharm class cs
- Azoles [CS]
- Pharm class moa
- Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- UNII
- R9400W927I