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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A205784-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205784-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205784-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205784-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-06-09 | 84e616aacf4f… | ||
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Actavis Pharma, Inc. | 72973b46-f307-4a9e-8fb1-ad2cbccfd736 | 2018-11-01 | Warnings, Adverse reactions | memantine hydrochloride MEMANTINE HYDROCHLORIDE |
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | c8f5c20b-4573-44c5-89fc-4da11b2e1fe1 | 2017-11-30 | Warnings, Adverse reactions | memantine hydrochloride MEMANTINE HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 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 |