Application 212791
- Type
- ANDA
- Sponsor
- SLAYBACK PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | No | No |
| 002 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | No | No |
| 003 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | |
| A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | |
| A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212791-001 | AP |
| A212791-002 | AP |
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 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212791-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212791-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | 2020-05-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212791-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2019-12-04 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A212791-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212791-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212791-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212791-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212791-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212791-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212791-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212791-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212791-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212791-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212791-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212791-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212791-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212791-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212791-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212791-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212791-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212791-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212791-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212791-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212791-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212791-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212791-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212791-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212791-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212791-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212791-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212791-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212791-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212791-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212791-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212791-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212791-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212791-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212791-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212791-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212791-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212791-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A212791-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A212791-002 | AP | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | CIVICA, INC. | 1faf1ac8-ff9b-4ed9-b562-06dab971173a | 2026-05-22 | Warnings, Adverse reactions | 212791 ANDA212791 72572-128 72572-127 |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | Wilshire Pharmaceuticals, Inc. | f550d2ba-49ac-4a3b-95db-692b468af479 | 2024-08-14 | Warnings, Adverse reactions | 212791 ANDA212791 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71225-126 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-126 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-126 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-126 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-132 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-132 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-132 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-133 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-133 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 71225-133 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | Slayback Pharma LLC | ANDA | Current |
| 72572-127 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | CIVICA, INC. | ANDA | Current |
| 72572-128 | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | CIVICA, INC. | ANDA | Current |