ACETAMINOPHEN
GLAND · ACETAMINOPHEN
Open FDA's page for this record- Application number
- ANDA219215
- Sponsor name
- GLAND
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20250402
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 002
- Reference drug
- No
- Brand name
- ACETAMINOPHEN
- Reference standard
- No
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Te code
- AP2
- Active ingredients
- Name
- ACETAMINOPHEN
- Strength
- 1GM/100ML (10MG/ML)
- Product number
- 001
- Reference drug
- No
- Brand name
- ACETAMINOPHEN
- Reference standard
- No
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Te code
- AP
- Active ingredients
- Name
- ACETAMINOPHEN
- Strength
- 500MG/50ML (10MG/ML)
- Harmonized identifiers (openFDA)
- Application number
- ANDA219215
- Brand name
- ACETAMINOPHEN
- Generic name
- ACETAMINOPHEN
- Manufacturer name
- Sagent Pharmaceuticals, Gland Pharma Limited
- Product NDC
- 25021-705, 68083-647, 68083-648
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- ACETAMINOPHEN
- RxCUI
- 483017, 2480095
- SPL ID
- eab98344-59bc-4da5-a30f-ab753c29f1f7, 04cdb516-3f83-45c4-a608-6a08b1fb6cf0
- SPL set ID
- 621282f6-75b3-401b-8e1a-c5153a0c9ecd, db5d4cf8-762a-4111-971e-91c704bc3643
- Package NDC
- 25021-705-82, 25021-705-87, 68083-647-01, 68083-648-01
- UNII
- 362O9ITL9D