Application 206986
- Type
- ANDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 002 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 003 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 004 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 005 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
| 006 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206986-001 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | |
| A206986-002 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | ||
| A206986-003 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | ||
| A206986-004 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | ||
| A206986-005 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | ||
| A206986-006 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-01-21 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 6a51e52b5d6a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-005 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206986-006 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-005 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206986-006 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-005 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206986-006 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-005 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206986-006 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Hysingla ER | HYDROCODONE BITARTRATE | Knoa Pharma LLC | b7d23ac2-e776-9f62-3290-c64c2d6eb353 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE |
| Hydrocodone Bitartrate | HYDROCODONE BITARTRATE | Alvogen Inc. | f7b55d14-0980-b680-8ceb-7489ff65455e | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate HYDROCODONE BITARTRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-409 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-409 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-409 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-410 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-410 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-410 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-411 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-411 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-411 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-412 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-412 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-412 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-413 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-413 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-413 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-414 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-414 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-414 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |