Application 212465
- Type
- ANDA
- Sponsor
- PADAGIS ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MUPIROCIN | MUPIROCIN CALCIUM | CREAM;TOPICAL | EQ 2% BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212465-001 | MUPIROCIN | MUPIROCIN CALCIUM | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 |
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 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | AB | 2022-08-03 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | AB | 2022-08-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | AB | 2022-08-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | AB | 2022-08-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | AB | 2022-08-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | AB | 2022-08-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | AB | 2022-08-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | AB | 2022-08-03 | e64feba35796… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212465-001 | MUPIROCIN | EQ 2% BASE | CREAM / TOPICAL | 2022-08-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212465-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212465-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212465-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A212465-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A212465-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212465-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A212465-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A212465-001 | AB | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Mupirocin | MUPIROCIN | Sun Pharmaceutical Industries, Inc. | 900bb675-2f03-47e3-854e-257ec4831332 | 2025-07-07 | Warnings, Adverse reactions | Mupirocin |
| mupirocin | MUPIROCIN | ATLANTIC BIOLOGICALS CORP. | da2f7d4e-82c6-4790-8eea-3a97e5b30734 | 2025-05-28 | Warnings, Adverse reactions | mupirocin |
| Mupirocin | MUPIROCIN OINTMENT | Kesin Pharma Corporation | b8e115ce-c8ff-4d08-b865-71dc4d0e51a1 | 2025-05-28 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | Lohxa | 6d59e35c-b262-7940-e053-2991aa0a8908 | 2025-03-25 | Warnings, Adverse reactions | Mupirocin |
| MUPIROCIN | MUPIROCIN | Alembic Pharmaceuticals Limited | 0580458d-7178-4031-8ac7-0cda281ade8b | 2025-03-18 | Warnings, Adverse reactions | MUPIROCIN |
| Mupirocin | MUPIROCIN | NuCare Pharmaceuticals,Inc. | 5abf8c5c-e9c9-3b59-e053-2a91aa0ae394 | 2025-01-02 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | Advanced Rx Pharmacy of Tennessee, LLC | f1a048d9-af57-a4a2-e053-2995a90a8663 | 2024-12-31 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | Advanced Rx Pharmacy of Tennessee, LLC | f1a01044-8f2e-4e91-e053-2995a90af722 | 2024-12-31 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | NuCare Pharmaceuticals,Inc. | 66db1071-024f-aa19-e053-2a91aa0a8e39 | 2024-06-06 | Warnings, Adverse reactions | Mupirocin |
| mupirocin | MUPIROCIN | A-S Medication Solutions | a6c22c25-0f02-4c06-bbc2-723a18ecdda8 | 2024-01-30 | Warnings, Adverse reactions | mupirocin |
| mupirocin | MUPIROCIN | Padagis Israel Pharmaceuticals Ltd | e9b61f01-3c67-42a4-a62b-10f1d1343190 | 2023-12-31 | Warnings, Adverse reactions | mupirocin |
| MUPIROCIN | MUPIROCIN | Alembic Pharmaceuticals Inc. | a69cd608-d2e6-4a7a-8cd7-f761bd333542 | 2023-12-11 | Warnings, Adverse reactions | MUPIROCIN |
| Mupirocin | MUPIROCIN | Proficient Rx LP | 2777e4f2-2b8d-41f5-a96a-02dec8c7c3e0 | 2023-11-01 | Warnings, Adverse reactions | Mupirocin |
| mupirocin | MUPIROCIN | Bryant Ranch Prepack | 1cd4c71f-138b-47c2-8ce8-9ac32408dc56 | 2023-07-18 | Warnings, Adverse reactions | mupirocin |
| Mupirocin | MUPIROCIN | Proficient Rx LP | d8766748-6b53-4673-a3ee-5cd8a4301647 | 2023-01-01 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | Proficient Rx LP | cbb18010-f3b5-4ed7-8c03-c9203f0e360e | 2022-10-01 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | Teva Pharmaceuticals USA, Inc. | a543797a-2c1c-4ea3-bd6c-227a784f92d9 | 2022-05-01 | Warnings, Adverse reactions | Mupirocin |
| mupirocin | MUPIROCIN | Proficient Rx LP | 97f8d67d-c422-4a26-9394-24a5ec9719d9 | 2022-04-01 | Warnings, Adverse reactions | mupirocin |
| Mupirocin | MUPIROCIN | Amneal Pharmaceuticals NY LLC | 648fe68b-da2d-47cc-b4d2-905d0ea588a5 | 2021-12-30 | Warnings, Adverse reactions | Mupirocin |
| mupirocin | MUPIROCIN | Asclemed USA, Inc. | b2ff9c56-ca19-48ca-bd08-4b33edb13a08 | 2020-11-09 | Warnings, Adverse reactions | mupirocin |
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 |
|---|---|---|---|---|---|
| 45802-018 | MUPIROCIN | mupirocin | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 63629-9439 | MUPIROCIN | mupirocin | Bryant Ranch Prepack | ANDA | Current |
| 63629-9440 | MUPIROCIN | mupirocin | Bryant Ranch Prepack | ANDA | Current |