Application 213070
- Type
- ANDA
- Sponsor
- STRIDES PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | CAPSULE;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213070-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 |
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 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 782e0a99824c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213070-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | 2021-08-11 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213070-001 | CGT | 2022-04-20 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213070-001 | CGT | 2022-04-20 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213070-001 | CGT | 2022-04-20 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213070-001 | CGT | 2022-04-20 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213070-001 | CGT | 2022-04-20 | 782e0a99824c… |
| 2023-01-26 05:58 UTC | 2023-01 | A213070-001 | CGT | 2022-04-20 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213070-001 | CGT | 2022-04-20 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A213070-001 | CGT | 2022-04-20 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A213070-001 | CGT | 2022-04-20 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213070-001 | CGT | 2022-04-20 | 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 |
|---|---|---|---|---|---|---|
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Strides Pharma, Inc. | 4178b3cc-e1ca-4912-8b1f-eac0110a3940 | 2026-08-13 | Warnings | 213070 ANDA213070 59556-959 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Dr. Reddy's Laboratories Inc. | 6fe91ddc-06b6-3a51-2b48-f6f11361ab73 | 2023-06-25 | Warnings | 213070 ANDA213070 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Dr. Reddy's Laboratories Inc. | 356d9432-d948-4b88-b297-9161b845f86b | 2023-06-25 | Warnings | 213070 ANDA213070 |
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68523 | ORIG | 2021-09-02 |