Application 219850
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
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 |
|---|---|---|---|---|---|---|---|
| A219850-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | |
| A219850-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | |
| A219850-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | |
| A219850-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219850-001 | AB |
| A219850-002 | AB |
| A219850-003 | AB |
| A219850-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A219850-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A219850-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A219850-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A219850-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A219850-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219850-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219850-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219850-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A219850-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219850-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219850-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219850-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219850-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219850-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219850-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219850-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219850-001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219850-002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219850-003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219850-004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | 2026-01-21 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A219850-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A219850-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A219850-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A219850-004 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A219850-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219850-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219850-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219850-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A219850-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219850-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219850-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219850-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A219850-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219850-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219850-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219850-004 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219850-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219850-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219850-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219850-004 | AB | 1 | a50c72e98297… |
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 | BUPRENORPHINE AND NALOXONE | Camber Pharmaceuticals, Inc. | 221195e4-de08-414c-af08-a611a74789de | 2026-01-30 | Warnings, Adverse reactions | 219850 ANDA219850 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.