SUGAMMADEX SODIUM
GLAND · SUGAMMADEX SODIUM
Open FDA's page for this record- Application number
- ANDA214364
- Sponsor name
- GLAND
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20260728
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Application docs
- ID
- 69663
- Url
- https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214364Orig1s000TAltr.pdf
- Date
- 20211220
- Type
- Letter
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- SUGAMMADEX SODIUM
- Reference standard
- No
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Te code
- AP
- Active ingredients
- Name
- SUGAMMADEX SODIUM
- Strength
- EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
- Product number
- 002
- Reference drug
- No
- Brand name
- SUGAMMADEX SODIUM
- Reference standard
- No
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Te code
- AP
- Active ingredients
- Name
- SUGAMMADEX SODIUM
- Strength
- EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
- Harmonized identifiers (openFDA)
- Application number
- ANDA214364
- Brand name
- SUGAMMADEX
- Generic name
- SUGAMMADEX
- Manufacturer name
- GLENMARK PHARMACEUTICALS INC., USA, Fosun Pharma USA Inc., Gland Pharma Limited
- Product NDC
- 68462-695, 68462-696, 72266-268, 72266-269, 68083-441, 68083-442
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- SUGAMMADEX SODIUM
- RxCUI
- 1726992, 1727000
- SPL ID
- e7897fc1-4553-460c-a29b-0bc91cd9ca10, 582676d1-997d-1623-e063-6294a90a7226, 6aaa0d1d-5de2-4a9c-8ac7-301c09579c3a
- SPL set ID
- e7897fc1-4553-460c-a29b-0bc91cd9ca10, 4f1c7cf8-3db7-3f92-e063-6394a90aece9, c61ee55a-e61b-4d3c-9ebc-cbf57290e36c
- Package NDC
- 68462-695-02, 68462-695-20, 68462-696-05, 68462-696-50, 72266-268-01, 72266-268-10, 72266-269-01, 72266-269-10, 68083-441-10, 68083-442-10
- UNII
- ERJ6X2MXV7