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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206986-005 | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206986-006 | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206986-001 | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2020-01-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206986-002 | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206986-003 | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206986-004 | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-01-21 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate | HYDROCODONE BITARTRATE | Alvogen Inc. | a7b8ea07-e926-f0a5-c20d-92f23ed350d0 | 2023-12-19 | Boxed warning, Warnings, Adverse reactions | 206986 ANDA206986 47781-412 47781-409 47781-413 47781-414 47781-410 47781-411 |
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 |