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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210162-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210162-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210162-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210162-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210162-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2021-05-03 | caaa826d4ba7… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| Buprenorphine | BUPRENORPHINE | Amneal Pharmaceuticals NY LLC | c7d079fb-507f-436f-b794-2171b7d97067 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | AvPAK | 1408cd8f-a0b5-6be7-e063-6394a90a0b41 | 2026-01-08 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| BRIXADI | BUPRENORPHINE | Braeburn Inc. | 5d8a8fd0-8619-422a-a664-d1d2e8970f48 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Redpharm Drug | 3dd00186-1f1f-642a-e063-6294a90a6d20 | 2025-12-02 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| buprenorphine transdermal system | BUPRENORPHINE | Alvogen Inc. | 315284b8-32ab-d34a-ea02-f501c6131bcc | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | a7da638f-f590-4577-bff9-15a91c6e7917 | 2025-07-29 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 9d976ee7-9509-49da-89fd-48d7e712697b | 2025-02-17 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 023c7816-21b1-4f85-be36-9e32d5935c19 | 2025-02-03 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | American Health Packaging | 8d38f7aa-da0b-40ad-b0d1-4284c71042ed | 2024-12-30 | Warnings, Adverse reactions | Buprenorphine BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 2181e700-caa1-48c4-90ce-60fec053ba6a | 2024-01-09 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 325532f0-276f-4689-97d6-cda879b4c758 | 2024-01-09 | Warnings, Adverse reactions | BUPRENORPHINE BUPRENORPHINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76472 | ORIG | 2023-11-07 |