Application 205954
- Type
- ANDA
- Sponsor
- ALVOGEN PINE BROOK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 2MG BASE;EQ 0.5MG BASE | No | No |
| 002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 4MG BASE;EQ 1MG BASE | No | No |
| 003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 8MG BASE;EQ 2MG BASE | No | No |
| 004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 12MG BASE;EQ 3MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | |
| A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | |
| A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | |
| A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205954-001 | AB |
| A205954-002 | AB |
| A205954-003 | AB |
| A205954-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205954-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205954-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205954-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205954-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2019-01-24 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205954-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205954-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205954-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205954-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205954-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205954-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205954-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205954-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205954-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205954-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205954-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205954-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205954-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205954-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205954-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205954-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205954-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205954-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205954-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205954-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205954-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205954-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205954-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205954-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205954-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205954-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205954-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205954-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205954-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205954-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205954-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205954-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205954-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205954-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205954-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205954-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205954-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205954-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205954-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205954-004 | AB | 1 | d06236e962d9… |
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 and Naloxone Sublingual Film | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 541bf5be-8b2c-99bc-e063-6294a90a2f17 | 2026-06-13 | Warnings, Adverse reactions | 205954 ANDA205954 |
| Buprenorphine and Naloxone Sublingual Film | BUPRENORPHINE AND NALOXONE | Alvogen Inc. | 4210afeb-474c-d842-d68e-af7e0021851a | 2026-01-01 | Warnings, Adverse reactions | 205954 ANDA205954 47781-356 47781-358 47781-355 47781-357 |
| Buprenorphine and Naloxone Sublingual Film | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 2fd16916-95a9-14b5-e063-6294a90a79fa | 2025-12-27 | Warnings, Adverse reactions | 205954 ANDA205954 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-355 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-355 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-355 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-355 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-355 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-355 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-355 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-356 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-356 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-356 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-356 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-356 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-356 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-356 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-357 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-357 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-357 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-357 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-357 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-357 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-357 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-358 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-358 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-358 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-358 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-358 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-358 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 47781-358 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Alvogen Inc. | ANDA | Current |
| 52427-692 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-692 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-692 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-692 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-694 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-694 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-694 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-694 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-698 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-698 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-698 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-698 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-712 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-712 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-712 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
| 52427-712 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Almatica Pharma Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76392 | ORIG | 2023-11-06 |