CEFEPIME HYDROCHLORIDE
HIKMA · CEFEPIME HYDROCHLORIDE
Open FDA's page for this record- Application number
- ANDA214402
- Sponsor name
- HIKMA
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20240522
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 002
- Reference drug
- No
- Brand name
- CEFEPIME HYDROCHLORIDE
- Reference standard
- No
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Te code
- AP
- Active ingredients
- Name
- CEFEPIME HYDROCHLORIDE
- Strength
- EQ 2GM BASE/VIAL
- Product number
- 001
- Reference drug
- No
- Brand name
- CEFEPIME HYDROCHLORIDE
- Reference standard
- No
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Te code
- AP
- Active ingredients
- Name
- CEFEPIME HYDROCHLORIDE
- Strength
- EQ 1GM BASE/VIAL
- Harmonized identifiers (openFDA)
- Application number
- ANDA214402
- Brand name
- CEFEPIME HYDROCHLORIDE
- Generic name
- CEFEPIME HYDROCHLORIDE
- Manufacturer name
- Hikma Pharmaceuticals USA Inc.
- Product NDC
- 0143-9477, 0143-9478, 0143-9382, 0143-9383
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Substance name
- CEFEPIME HYDROCHLORIDE
- RxCUI
- 1665088, 1665093
- SPL ID
- 683dbeca-503f-4314-b4d0-5386b08b19cc, c31d1803-2676-4944-92ef-0f6f5e3fee16
- SPL set ID
- f64c181e-28c5-48ab-aa67-5ca0e3fd079c, b9914e7e-13f6-42d4-9cbb-8c7ed1ce7a01
- Package NDC
- 0143-9477-01, 0143-9477-10, 0143-9478-01, 0143-9478-10, 0143-9382-10, 0143-9383-10
- UNII
- I8X1O0607P