Application 210162
- Type
- ANDA
- Sponsor
- MYLAN TECHNOLOGIES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 5MCG/HR | No | No |
| 002 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 7.5MCG/HR | No | No |
| 003 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 10MCG/HR | No | No |
| 004 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 15MCG/HR | No | No |
| 005 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 20MCG/HR | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210162-001 | BUPRENORPHINE | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | ||
| A210162-002 | BUPRENORPHINE | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | ||
| A210162-003 | BUPRENORPHINE | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | ||
| A210162-004 | BUPRENORPHINE | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | ||
| A210162-005 | BUPRENORPHINE | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| SUBLOCADE | BUPRENORPHINE | Indivior Inc. | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | REMEDYREPACK INC. | aa86a438-1ebf-4c08-bf27-38f1e81efb3a | 2026-07-07 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5578cd5c-c860-6e8a-e063-6394a90a56c7 | 2026-06-30 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | aa132031-9d12-45b4-81e0-4a5877661379 | 2026-06-29 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Bryant Ranch Prepack | 655e3e52-03be-496c-978a-5cffc74b2ae4 | 2026-06-29 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5479b218-a388-2c3c-e063-6294a90a0e85 | 2026-06-17 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | 966adb01-71b4-4e0b-bbc6-b83da9987aa2 | 2026-06-16 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Major Pharmaceuticals | dba586f9-e3f2-4b9c-849b-907c81a5a0ef | 2026-06-16 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | bc5a7137-9e8f-438e-84d9-bdbf1db12998 | 2026-06-03 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Rhodes Pharmaceuticals LLC | 2738feae-316e-426f-971c-5f142ac01b60 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Actavis Pharma, Inc. | 03819118-86f6-4329-adaf-4599e7b71f46 | 2026-05-25 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Teva Pharmaceuticals USA, Inc. | 36995ce3-b515-447b-baa9-aa14f84060d8 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Rhodes Pharmaceuticals LLC | da90618a-5621-4b15-bc48-9dcc631418de | 2026-05-04 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| Butrans | BUPRENORPHINE | Knoa Pharma LLC | 794aa355-66de-41b8-aedf-f2c40f6bc664 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | INGENUS PHARMACEUTICALS, LLC | 186e3be6-8bc0-4bb9-96f5-429d53632f45 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Aveva Drug Delivery Systems Inc. | 1aae9b13-7431-42ef-8558-14a2325820e6 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | cd0a90c6-32cc-4114-8573-86ac85503bdf | 2026-04-03 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Sun Pharmaceutical Industries, Inc. | 9fd1f18f-0b0f-4059-b603-19ecbf0ed63a | 2026-02-11 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | A-S Medication Solutions | bfb02ea5-22f2-432e-afc8-f1dbe2ea0614 | 2026-02-06 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Hikma Pharmaceuticals USA Inc. | 1bf8b35a-b769-465c-a2f8-099868dfcd2f | 2026-01-24 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76472 | ORIG | 2023-11-07 |