Application 076141
- Type
- ANDA
- Sponsor
- HI TECH PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMBELINE | CLOBETASOL PROPIONATE | GEL;TOPICAL | 0.05% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076141-001 | EMBELINE | CLOBETASOL PROPIONATE | 0.05% | GEL / TOPICAL | 2002-04-12 |
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 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | 2002-04-12 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A076141-001 | EMBELINE | 0.05% | GEL / TOPICAL | AB | 2002-04-12 | 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 | A076141-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076141-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076141-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076141-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076141-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076141-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076141-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076141-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076141-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076141-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076141-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076141-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076141-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076141-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076141-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076141-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076141-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076141-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076141-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076141-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076141-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076141-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076141-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076141-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A076141-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076141-001 | 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 | NuCare Pharmaceuticals, Inc. | 4524d04c-de48-6671-e063-6294a90a0e33 | 2025-12-04 | Adverse reactions | CLOBETASOL PROPIONATE |
| clobetasol propionate | CLOBETASOL PROPIONATE | Padagis Israel Pharmaceuticals Ltd | 49bfff2e-9e4d-48a4-9f74-d6cf5b312aca | 2025-11-30 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 4990e4c7-78b3-4bc8-85d0-6d58f08121ff | 2025-11-04 | Adverse reactions | CLOBETASOL PROPIONATE |
| clobetasol propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 40c3b94f-a61c-4fc1-a411-5bf4e3fe6791 | 2025-10-21 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Lupin Pharmaceuticals, Inc. | 0a267001-0bff-471c-8852-808e6e3ea37c | 2025-10-14 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Lupin Pharmaceuticals, Inc. | 93f3763f-9f2f-4e81-bf6c-db35af45cd64 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | f0ca99cd-6c54-44f8-a9b3-432e93fc5d59 | 2025-10-08 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate (emollient) | CLOBETASOL PROPIONATE | The J. Molner Company LLC | 26ccb1d8-c466-e238-e063-6394a90a0069 | 2025-10-02 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 9856b731-0676-405d-817c-de385cbd08a3 | 2025-09-30 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 643682ee-39c8-4a0d-b131-f30077e6e20a | 2025-09-03 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 21a63bc2-a42a-412c-8dd5-17e279f99f27 | 2025-09-03 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 6d14d269-bae6-493a-81ed-83f6a3aa0f4f | 2025-09-03 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Sun Pharmaceutical Industries, Inc. | 91571297-03ad-441e-8ec6-f78c21fbe5e8 | 2025-08-22 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Xiromed, LLC | 2556987f-4b0f-8a83-5bf4-095d67a450b4 | 2025-08-12 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | NORTHSTAR RX LLC | 72c90da7-5f6a-4b8d-875d-f07ceeec295e | 2025-07-09 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 2025-07-08 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Sun Pharmaceutical Industries, Inc. | 04d7d65b-d7ed-4223-abab-5d0aed36a155 | 2025-07-07 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Sun Pharmaceutical Industries, Inc. | d4c73fb0-9675-4c41-a8bd-dd4cb2db1169 | 2025-07-07 | Warnings, Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Sun Pharmaceutical Industries, Inc. | f5ea346b-f507-4224-88a6-4c891c4b1ad5 | 2025-07-03 | Adverse reactions | CLOBETASOL PROPIONATE |
| Clobetasol Propionate | CLOBETASOL PROPIONATE | Sun Pharmaceutical Industries, Inc. | d8246614-757b-4e27-8c3e-37fcb401e6d9 | 2025-07-03 | Warnings, 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 |
|---|---|---|---|---|---|
| 50383-269 | Clobetasol Propionate | Clobetasol Propionate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-269 | Clobetasol Propionate | Clobetasol Propionate | Akorn | ANDA | Current |
| 50383-269 | Clobetasol Propionate | Clobetasol Propionate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8869 | ORIG | 2003-04-10 |