DIAZEPAM
BAXTER HLTHCARE CORP · DIAZEPAM
Open FDA's page for this record- Application number
- ANDA219882
- Sponsor name
- BAXTER HLTHCARE CORP
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20260728
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 002
- Reference drug
- No
- Brand name
- DIAZEPAM
- Reference standard
- Yes
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Active ingredients
- Name
- DIAZEPAM
- Strength
- 20MG/4ML (5MG/ML)
- Product number
- 001
- Reference drug
- No
- Brand name
- DIAZEPAM
- Reference standard
- No
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Te code
- AP
- Active ingredients
- Name
- DIAZEPAM
- Strength
- 10MG/2ML (5MG/ML)
- Harmonized identifiers (openFDA)
- Application number
- ANDA219882
- Brand name
- DIAZEPAM
- Generic name
- DIAZEPAM
- Manufacturer name
- Baxter Healthcare Corporation
- Product NDC
- 43066-121, 43066-123
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Substance name
- DIAZEPAM
- RxCUI
- 2120550, 2749119
- SPL ID
- a0813073-d0b0-4fd7-b307-56f69c910c82
- SPL set ID
- a0813073-d0b0-4fd7-b307-56f69c910c82
- Package NDC
- 43066-121-01, 43066-121-10, 43066-123-01, 43066-123-10
- Nui
- N0000175694, M0002356
- Pharm class epc
- Benzodiazepine [EPC]
- Pharm class cs
- Benzodiazepines [CS]
- UNII
- Q3JTX2Q7TU