Application 205784
- Type
- ANDA
- Sponsor
- ANCHEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 7MG | No | No |
| 002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 14MG | No | No |
| 003 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 21MG | No | No |
| 004 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 28MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205784-001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | ||
| A205784-002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | ||
| A205784-003 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | ||
| A205784-004 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 |
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 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | d8e5a09893c0… |
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 | A205784-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205784-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205784-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205784-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205784-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205784-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205784-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205784-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205784-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205784-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205784-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205784-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205784-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205784-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205784-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205784-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205784-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205784-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205784-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205784-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205784-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205784-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205784-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205784-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205784-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205784-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205784-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205784-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A205784-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A205784-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A205784-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A205784-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A205784-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A205784-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A205784-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A205784-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A205784-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A205784-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A205784-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A205784-004 | AB | 1 | c0c555d07b60… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10370-346 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-346 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-346 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-346 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-347 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-347 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-347 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-347 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-348 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-348 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-348 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-348 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-349 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-349 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-349 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-349 | Memantine Hydrochloride | Memantine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 51407-054 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-054 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-054 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-054 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-055 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-055 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-055 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-055 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-056 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-056 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-056 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-056 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-056 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-057 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-057 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-057 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-057 | Memantine Hydrochloride | Memantine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 63629-2222 | Memantine Hydrochloride | Memantine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2222 | Memantine Hydrochloride | Memantine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2223 | Memantine Hydrochloride | Memantine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2223 | Memantine Hydrochloride | Memantine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |