Application 089683
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PERPHENAZINE | PERPHENAZINE | TABLET;ORAL | 2MG | 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 |
|---|---|---|---|---|---|---|
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | 9588d223-41e4-4bb2-9306-f082498404c5 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | cf41a02d-c881-4b40-b99c-d5b79dbd645b | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | da5519cd-7b96-4468-910c-87dffdb1888e | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | fc903628-248c-4d12-88b4-a551aeadb4d2 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | bb08cedf-18ab-4341-a84e-c092ff7a5c98 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| perphenazine | PERPHENAZINE | REMEDYREPACK INC. | 1fc98e41-17d1-4491-87ed-ff7651422b5b | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | 1a216d3f-12b0-44c2-b7d3-109fee45978d | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | 8028ab47-a6de-4924-a4cd-9336fa90dd90 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Chartwell RX, LLC | ba5f3963-3080-48bc-806a-0aed72e2c25b | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | American Health Packaging | a17c90f9-3d5d-4503-ba2c-754b45decbf8 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | aaa1127a-393d-454a-b68a-b1f206117f3b | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| PERPHENAZINE | PERPHENAZINE | REMEDYREPACK INC. | c4150683-0772-4344-bb1c-f050b84175d6 | 2025-09-26 | Boxed warning, Warnings, Adverse reactions | PERPHENAZINE PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | f6af1fc3-868d-46f3-8bbe-828375fb0fae | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | e2e52bd9-b9c2-4f04-af03-bdb54b48c16c | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | afaea32d-0dc1-4dcb-9ee2-dd2937ec030e | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | 41758282-6848-4a47-bbf3-89edc270f7b3 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Major Pharmaceuticals | 0dc77ea9-32ee-4b6d-b69d-8c712bcf5fe4 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Actavis Pharma, Inc. | bb1a3d20-1f93-48a1-9e27-4712a8561757 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| perphenazine | PERPHENAZINE | Golden State Medical Supply, Inc. | f0ea4d18-643d-7acb-e053-2a95a90a9ea7 | 2024-12-23 | Boxed warning, Warnings, Adverse reactions | perphenazine PERPHENAZINE |
| PERPHENAZINE | PERPHENAZINE | Rising Pharma Holdings, Inc. | 0ebf4c11-1810-42f6-a8e3-071616e33d5d | 2024-12-12 | Boxed warning, Warnings, Adverse reactions | PERPHENAZINE PERPHENAZINE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-3584 | Perphenazine | Perphenazine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-3585 | Perphenazine | Perphenazine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-4511 | Perphenazine | Perphenazine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 70518-1770 | Perphenazine | Perphenazine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1770 | Perphenazine | Perphenazine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1770 | Perphenazine | Perphenazine | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18527 | SUPPL | 2013-12-11 |