Application 211586
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS LLC
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 |
|---|---|---|---|---|---|---|---|
| A211586-001 | BUPRENORPHINE | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | |
| A211586-002 | BUPRENORPHINE | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | |
| A211586-003 | BUPRENORPHINE | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | |
| A211586-004 | BUPRENORPHINE | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | |
| A211586-005 | BUPRENORPHINE | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211586-001 | AB |
| A211586-002 | AB |
| A211586-003 | AB |
| A211586-004 | AB |
| A211586-005 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211586-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211586-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211586-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211586-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211586-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-002 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-003 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-004 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-005 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2020-04-14 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211586-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211586-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211586-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211586-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211586-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211586-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211586-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211586-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211586-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211586-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211586-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211586-005 | AB | 1 | 2680178bc6a6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-22 03:56 UTC | 2020-12 | A211586-002 | CGT | 2020-10-13 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A211586-002 | CGT | 2020-10-13 | c0c555d07b60… |
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 | 211586 ANDA211586 69238-1204 69238-1203 69238-1205 69238-1505 69238-1202 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69238-1202 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1202 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1202 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1203 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1203 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1203 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1204 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1204 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1204 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1205 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1205 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1205 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1505 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1505 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1505 | Buprenorphine | Buprenorphine | Amneal Pharmaceuticals NY LLC | ANDA | Current |