Application 022547
- Type
- NDA
- Sponsor
- CIPLA LIMITED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ABACAVIR SULFATE | ABACAVIR SULFATE | TABLET; ORAL | 60MG | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Abacavir Sulfate | ABACAVIR SULFATE | Safecor Health, LLC | f7633480-25aa-4326-bec9-82835b486a20 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Abacavir Sulfate ABACAVIR SULFATE |
| Abacavir Sulfate | ABACAVIR SULFATE | Mylan Institutional Inc. | 80c1702a-973c-436a-90f8-69b29674dca0 | 2025-07-17 | Boxed warning, Warnings, Adverse reactions | Abacavir Sulfate ABACAVIR SULFATE |
| Abacavir | ABACAVIR SULFATE | Rising Pharma Holdings, Inc. | ec9e2c36-b9b7-4ac2-a366-f3ad51237f28 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | ABACAVIR SULFATE |
| Abacavir | ABACAVIR SULFATE | Aurobindo Pharma Limited | e2214976-657c-4018-b059-1ad66a7e2b6f | 2024-05-08 | Boxed warning, Warnings, Adverse reactions | ABACAVIR SULFATE |
| ZIAGEN | ABACAVIR SULFATE | ViiV Healthcare Company | ca73b519-015a-436d-aa3c-af53492825a1 | 2023-09-29 | Boxed warning, Warnings, Adverse reactions | ABACAVIR SULFATE |
| Abacavir Sulfate | ABACAVIR SULFATE | Mylan Pharmaceuticals Inc. | 5676d391-f9a4-44be-9604-954b3d8d0e2b | 2021-01-08 | Boxed warning, Warnings, Adverse reactions | Abacavir Sulfate ABACAVIR SULFATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 29852 | ORIG | 2011-03-08 |