PegIntron/ Rebetol Combo Pack Purple Book BLA 125196
- BLA number
- 125196
- Proprietary names
- PegIntron/ Rebetol Combo Pack
- Proper names
- peginterferon alfa-2b and ribavirin
- Applicant
- Schering Corporation a subsidiary of Merck & Co., Inc.
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | 351(a) | 50MCG/0.5ML & 200MG | | | | Disc | Voluntarily Revoked | 2008-06-13 | |
| 002 | PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | 351(a) | 80MCG/0.5ML & 200MG | | | | Disc | Voluntarily Revoked | 2008-06-13 | |
| 003 | PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | 351(a) | 120MCG/0.5ML & 200MG | | | | Disc | Voluntarily Revoked | 2008-06-13 | |
| 004 | PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | 351(a) | 150MCG/0.5ML & 200MG | | | | Disc | Voluntarily Revoked | 2008-06-13 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2020-05-01 | R | 001 | PegIntron/ Rebetol Combo Pack | 351(a) | Disc | Schering Corporation a subsidiary of Merck & Co., Inc. |
| 2020-05-01 | R | 002 | PegIntron/ Rebetol Combo Pack | 351(a) | Disc | Schering Corporation a subsidiary of Merck & Co., Inc. |
| 2020-05-01 | R | 003 | PegIntron/ Rebetol Combo Pack | 351(a) | Disc | Schering Corporation a subsidiary of Merck & Co., Inc. |
| 2020-05-01 | R | 004 | PegIntron/ Rebetol Combo Pack | 351(a) | Disc | Schering Corporation a subsidiary of Merck & Co., Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | PegIntron/ Rebetol Combo Pack | 351(a) | Disc | Voluntarily Revoked | 2008-06-13 |
| 2020-05-01 | 002 | PegIntron/ Rebetol Combo Pack | 351(a) | Disc | Voluntarily Revoked | 2008-06-13 |
| 2020-05-01 | 003 | PegIntron/ Rebetol Combo Pack | 351(a) | Disc | Voluntarily Revoked | 2008-06-13 |
| 2020-05-01 | 004 | PegIntron/ Rebetol Combo Pack | 351(a) | Disc | Voluntarily Revoked | 2008-06-13 |