Application 202002
- Type
- ANDA
- Sponsor
- STRIDES PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMIQUIMOD | IMIQUIMOD | CREAM;TOPICAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202002-001 | IMIQUIMOD | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 |
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 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202002-001 | IMIQUIMOD | 5% | CREAM / TOPICAL | 2014-06-24 | 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 |
|---|---|---|---|---|---|---|
| Imiquimod | IMIQUIMOD | Sun Pharmaceutical Industries, Inc. | 51913a5a-1cab-4b9e-b2c2-e0174062df73 | 2026-01-21 | Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| Imiquimod | IMIQUIMOD | Bryant Ranch Prepack | 9291e5cd-b83d-4b43-88f5-30cac6cef5ff | 2025-11-05 | Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| Imiquimod | IMIQUIMOD | Bryant Ranch Prepack | f8db59e2-8052-413b-9f9f-07cd9eea07ec | 2025-09-25 | Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| Imiquimod | IMIQUIMOD | Sun Pharmaceutical Industries, Inc. | 59af8153-4cf8-4f22-9000-f239798d52d1 | 2025-08-11 | Boxed warning, Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| Imiquimod | IMIQUIMOD | Bryant Ranch Prepack | 47d3045f-a145-4095-bb8a-c67ba1ff3bda | 2025-07-29 | Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| Imiquimod | IMIQUIMOD | Teva Pharmaceuticals USA, Inc. | 9f2cbefd-f295-47e2-8a9e-3e7c5812c963 | 2025-06-30 | Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| Imiquimod | IMIQUIMOD | Oceanside Pharmacueticals | d86eeb0e-70e0-4c72-aaa3-37daa1d8611e | 2025-06-03 | Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| Zyclara | IMIQUIMOD | Bausch Health US, LLC | 28cd9b5b-680b-480f-b33d-9c5b52bbf03d | 2025-05-23 | Warnings, Adverse reactions | IMIQUIMOD |
| Imiquimod | IMIQUIMOD | Padagis Israel Pharmaceuticals Ltd | 1505cf54-37da-4b2b-9812-6ffd6a01a7c7 | 2025-01-31 | Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| Imiquimod | IMIQUIMOD | Glenmark Pharmaceuticals Inc., USA | 663e39a9-a29e-473f-89ec-4c7c6bc27b8a | 2025-01-23 | Warnings, Adverse reactions | Imiquimod IMIQUIMOD |
| IMIQUIMOD | IMIQUIMOD | DIRECT RX | a18a3f7e-7254-56c0-e053-2a95a90a7036 | 2025-01-17 | Warnings, Adverse reactions | IMIQUIMOD IMIQUIMOD |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64380-773 | imiquimod | imiquimod | Strides Shasun Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9939 | ORIG | 2014-06-26 |