Application 077800
- Type
- ANDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.0103% BASE | No | No |
| 002 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.021% BASE | No | No |
| 003 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.042% BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077800-001 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | ||
| A077800-002 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | ||
| A077800-003 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 |
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 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077800-002 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | 2013-03-15 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077800-003 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | 2013-03-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077800-001 | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | 2013-03-15 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | A077800-001 | AN | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077800-002 | AN | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077800-003 | AN | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077800-001 | AN | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077800-002 | AN | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077800-003 | AN | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Redpharm Drug | 56cb1f4b-ddf4-0661-e063-6394a90a9c45 | 2026-07-17 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Ritedose Pharmaceuticals, LLC | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 2025-12-10 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Bryant Ranch Prepack | e7e3d858-6a0d-482c-b71b-de90d3ef3169 | 2023-09-14 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Bryant Ranch Prepack | d4080fc5-50d6-49a9-8a63-7769d201968d | 2023-09-14 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Bryant Ranch Prepack | 2f416dc8-62aa-4b6b-a745-2c8a72bb763d | 2023-09-13 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | A-S Medication Solutions | 262c0b8b-8461-4bdf-b272-c829d33fd451 | 2023-02-28 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Burel Pharmaceuticals, LLC | 737fe40b-798b-4d7f-bec9-7af952018ab5 | 2021-07-01 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | e5c8368a-49f9-45cf-9d42-a871f005edb9 | 2019-06-29 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-9680 | Levalbuterol | levalbuterol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9681 | Levalbuterol | levalbuterol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9682 | Levalbuterol | levalbuterol | Mylan Pharmaceuticals Inc. | ANDA | Current |