Application 074221
- Type
- ANDA
- Sponsor
- HI TECH PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMBELINE | CLOBETASOL PROPIONATE | OINTMENT;TOPICAL | 0.05% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074221-001 | EMBELINE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | 1995-03-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A074221-001 | EMBELINE | 0.05% | OINTMENT / TOPICAL | AB | 1995-03-31 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074221-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A074221-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A074221-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A074221-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A074221-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A074221-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074221-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A074221-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A074221-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A074221-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A074221-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A074221-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A074221-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074221-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A074221-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A074221-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074221-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074221-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074221-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074221-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A074221-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A074221-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074221-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A074221-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A074221-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A074221-001 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | Alembic Pharmaceuticals Limited | 6fc0d1ac-f357-4038-8004-263bfaed4eaf | 2025-04-25 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | Eyenovia, Inc. | 7687c980-7006-4222-80b9-c32773772d3e | 2025-04-16 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| clobetasol propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 2d0b48d9-dbfb-4265-b73b-07faf217ae6e | 2025-04-02 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Alembic Pharmaceuticals Inc. | fc3ac7b5-0cd5-4d31-97e4-b01c0f715835 | 2025-03-28 | Adverse reactions | CLOBETASOL PROPIONATE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | Alembic Pharmaceuticals Limited | a4f74fc7-d2f6-4cf2-9cc5-60078bde55a7 | 2025-03-26 | Adverse reactions | CLOBETASOL PROPIONATE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | Alembic Pharmaceuticals Limited | 46bda1db-c2eb-461a-bcd0-dfdb6c7f542d | 2025-03-18 | Adverse reactions | CLOBETASOL PROPIONATE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | Alembic Pharmaceuticals Limited | 2b7f0643-679c-4586-a3a0-31eae4a36f19 | 2025-03-18 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | INA Pharmaceutics Inc | 1b0e9eb5-71eb-44b4-894a-094a9f325dc8 | 2025-02-13 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Alembic Pharmaceuticals Limited | 1a4331e1-5c79-44c3-a691-4b808a3bde97 | 2025-02-12 | Adverse reactions | CLOBETASOL PROPIONATE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | Alembic Pharmaceuticals Limited | 96f20fcd-aa96-4472-807b-43094befc8a9 | 2025-02-10 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Macleods Pharmaceuticals Limited | 44ced6ce-fa10-426d-a498-a13b8b34f49a | 2025-01-29 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | DIRECT RX | cc716dab-b535-8b51-e053-2995a90a8f16 | 2025-01-20 | Adverse reactions | CLOBETASOL PROPIONATE |
| Tovet (emollient formulation) | CLOBETASOL PROPIONATE | Medimetriks Pharmaceuticals, Inc. | 4d5c5b14-9e4f-4d43-a336-e4ae71d34e42 | 2024-12-12 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| clobetasol propionate | CLOBETASOL PROPIONATE | Zydus Lifesciences Limited | 287ce325-4449-4342-a9ef-a7e31ee692bd | 2024-11-26 | CLOBETASOL PROPIONATE | |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | Zydus Lifesciences Limited | 30f4c173-189d-4b29-8d7d-e82e5c0743cf | 2024-11-26 | CLOBETASOL PROPIONATE | |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 1bdc1978-00d1-43f4-a127-a9d9c709644d | 2024-10-30 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Viona Pharmaceuticals Inc | 2fc7de5f-094f-400c-b87e-750b16046f46 | 2024-08-16 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Zydus Lifesciences Limited | d01b8f72-c2d2-49d8-87d7-3d60f11a7bbb | 2024-08-14 | CLOBETASOL PROPIONATE | |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | Alembic Pharmaceuticals Inc. | 0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb | 2024-03-14 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Proficient Rx LP | e0f7bc85-9c13-44df-9b37-c216ecfe3ffe | 2024-03-01 | Adverse reactions | CLOBETASOL PROPIONATE |
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 |
|---|---|---|---|---|---|
| 42254-174 | Clobetasol Propionate | Clobetasol Propionate | Rebel Distributors Corp | ANDA | Current |
| 50090-4647 | Clobetasol Propionate | Clobetasol Propionate | A-S Medication Solutions | ANDA | Current |
| 50090-4647 | Clobetasol Propionate | Clobetasol Propionate | A-S Medication Solutions | ANDA | Current |
| 50383-268 | Clobetasol Propionate | Clobetasol Propionate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-268 | Clobetasol Propionate | Clobetasol Propionate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-268 | Clobetasol Propionate | Clobetasol Propionate | Akorn | ANDA | Current |
| 50383-268 | Clobetasol Propionate | Clobetasol Propionate | Akorn | ANDA | Current |
| 68788-0332 | Clobetasol Propionate | Clobetasol Propionate | Preferred Pharmaceuticals, Inc. | ANDA | Current |