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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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 | Preferred Pharmaceuticals Inc. | 6c9cd7fc-b72e-406e-b9aa-0f1bc035b832 | 2026-07-28 | Warnings, Adverse reactions | mupirocin |
| Mupirocin | MUPIROCIN | Preferred Pharmaceuticals Inc. | 06a4ee22-d8f8-4a8a-8666-82b14f2d8476 | 2026-07-28 | Warnings, Adverse reactions | Mupirocin |
| mupirocin | MUPIROCIN | HAWAII REPACK, INC. | 7eaa296c-3f98-4f11-b4c1-62c2bc22a9a1 | 2026-07-27 | Warnings, Adverse reactions | mupirocin |
| mupirocin | MUPIROCIN | St. Mary's Medical Park Pharmacy | 235c4f77-e751-a69f-e063-6394a90a1f96 | 2026-06-10 | Warnings, Adverse reactions | mupirocin |
| Mupirocin | MUPIROCIN CALCIUM | REMEDYREPACK INC. | 9a1be092-6fe8-4b7c-a668-e584783f888b | 2026-06-05 | Warnings, Adverse reactions | Mupirocin MUPIROCIN CALCIUM |
| Mupirocin | MUPIROCIN | Sportpharm LLC | c70dd5d7-6995-4a3d-b19c-9b4a2cfe3da9 | 2026-05-12 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | Sportpharm LLC | e250adda-52a5-486f-a43d-2cc486dbe2a8 | 2026-05-04 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN CALCIUM | Sun Pharmaceutical Industries, Inc. | 6719ffba-3430-4fa9-b65b-c5c195ee1b35 | 2026-04-10 | Warnings, Adverse reactions | Mupirocin MUPIROCIN CALCIUM |
| Mupirocin | MUPIROCIN CALCIUM | NORTHSTAR RX LLC | 6f1c0789-4a3b-473a-96d6-0c479ee32d36 | 2026-04-10 | Warnings, Adverse reactions | Mupirocin MUPIROCIN CALCIUM |
| MUPIROCIN | MUPIROCIN | DIRECT RX | f88eea1a-2ba1-48bf-96c8-d96d18752aaa | 2026-03-20 | Warnings, Adverse reactions | MUPIROCIN |
| Mupirocin | MUPIROCIN | PAI Holdings, LLC dba PAI Pharma | a822d44d-c651-406c-a2b9-aa8fbe8f89ce | 2026-03-17 | Warnings, Adverse reactions | Mupirocin |
| MUPIROCIN | MUPIROCIN | Redpharm Drug | 49eb7289-c44d-75e1-e063-6294a90a2283 | 2026-02-03 | Warnings, Adverse reactions | MUPIROCIN |
| mupirocin | MUPIROCIN | REMEDYREPACK INC. | 290b4e51-59b4-429a-987b-715ac817ef2c | 2026-01-28 | Warnings, Adverse reactions | mupirocin |
| Mupirocin | MUPIROCIN | AvPAK | 8b10c706-ae9c-fc76-e053-2a95a90a4c73 | 2026-01-20 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | Glenmark Pharmaceuticals Inc., USA | ff7428fb-9ce9-4743-b58c-01a05424a57a | 2025-10-28 | Warnings, Adverse reactions | Mupirocin |
| mupirocin | MUPIROCIN | Bryant Ranch Prepack | 6cef3abf-9f17-459e-86b9-95896d9620b7 | 2025-10-24 | Warnings, Adverse reactions | mupirocin |
| mupirocin | MUPIROCIN | Bryant Ranch Prepack | 7e7675fb-4bfa-46ac-ac1b-0918593d63ee | 2025-10-08 | Warnings, Adverse reactions | mupirocin |
| MUPIROCIN | MUPIROCIN | Encube Ethicals, Inc. | 95c302b8-affa-431a-9b89-0506f5a098e6 | 2025-10-08 | Warnings, Adverse reactions | MUPIROCIN |
| Mupirocin | MUPIROCIN | Encube Ethicals, Inc. | cb085bdf-e371-6e8a-e053-2995a90ae358 | 2025-09-26 | Warnings, Adverse reactions | Mupirocin |
| Mupirocin | MUPIROCIN | Sun Pharmaceutical Industries, Inc. | 900bb675-2f03-47e3-854e-257ec4831332 | 2025-07-07 | Warnings, Adverse reactions | Mupirocin |
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 |