IBUPROFEN AND FAMOTIDINE
ZYDUS LIFESCIENCES · FAMOTIDINE, IBUPROFEN
Open FDA's page for this record- Application number
- ANDA218684
- Sponsor name
- ZYDUS LIFESCIENCES
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20250220
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- IBUPROFEN AND FAMOTIDINE
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- FAMOTIDINE
- Strength
- 26.6MG
- Name
- IBUPROFEN
- Strength
- 800MG
- Harmonized identifiers (openFDA)
- Application number
- ANDA218684
- Brand name
- IBUPROFEN AND FAMOTIDINE
- Generic name
- IBUPROFEN AND FAMOTIDINE
- Manufacturer name
- Viona Pharmaceuticals Inc, Zydus Lifesciences Limited
- Product NDC
- 72578-214, 70771-1924
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- IBUPROFEN, FAMOTIDINE
- RxCUI
- 1100066
- SPL ID
- d0498b4c-d60a-4a93-b151-d3bc4658787a, 099f42a7-f7c9-49f0-8b83-74670cc8124a
- SPL set ID
- 66524c84-35bc-4e7f-897a-f63fa4bca432, 24204938-0989-42ad-8ad8-89979e62d700
- Package NDC
- 72578-214-16, 70771-1924-9
- Nui
- N0000000160, M0001335, N0000175722, N0000000151, N0000175784
- Pharm class moa
- Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA]
- Pharm class cs
- Anti-Inflammatory Agents, Non-Steroidal [CS]
- Pharm class epc
- Nonsteroidal Anti-inflammatory Drug [EPC], Histamine-2 Receptor Antagonist [EPC]
- UNII
- WK2XYI10QM, 5QZO15J2Z8