Application 205003
- Type
- NDA
- Sponsor
- ADHERA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRESTALIA | AMLODIPINE BESYLATE; PERINDOPRIL ARGININE | TABLET;ORAL | EQ 2.5MG BASE;3.5MG | Yes | No |
| 002 | PRESTALIA | AMLODIPINE BESYLATE; PERINDOPRIL ARGININE | TABLET;ORAL | EQ 5MG BASE;7MG | Yes | No |
| 003 | PRESTALIA | AMLODIPINE BESYLATE; PERINDOPRIL ARGININE | TABLET;ORAL | EQ 10MG BASE;14MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205003-001 | PRESTALIA | AMLODIPINE BESYLATE; PERINDOPRIL ARGININE | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | |
| N205003-002 | PRESTALIA | AMLODIPINE BESYLATE; PERINDOPRIL ARGININE | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | |
| N205003-003 | PRESTALIA | AMLODIPINE BESYLATE; PERINDOPRIL ARGININE | EQ 10MG BASE;14MG | TABLET / ORAL | RLD | 2015-01-21 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 |
| N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 |
| N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N205003-003 | PRESTALIA | EQ 10MG BASE;14MG | TABLET / ORAL | RLD, RS | 2015-01-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N205003-001 | PRESTALIA | EQ 2.5MG BASE;3.5MG | TABLET / ORAL | RLD | 2015-01-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N205003-002 | PRESTALIA | EQ 5MG BASE;7MG | TABLET / ORAL | RLD | 2015-01-21 | c0c555d07b60… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N205003-002 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N205003-003 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205003-001 | 7846961 | 2029-10-05 | U-3 | Drug substance, Drug product | 2015-12-29 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|
| 61894-010 | Prestalia | perindopril arginine, amlodipine besylate | Marina BioTech | NDA | Current |
| 61894-010 | Prestalia | perindopril arginine, amlodipine besylate | Marina BioTech | NDA | Current |
| 61894-011 | Prestalia | perindopril arginine, amlodipine besylate | Marina BioTech | NDA | Current |
| 61894-011 | Prestalia | perindopril arginine, amlodipine besylate | Marina BioTech | NDA | Current |
| 61894-012 | Prestalia | perindopril arginine, amlodipine besylate | Marina BioTech | NDA | Current |
| 61894-012 | Prestalia | perindopril arginine, amlodipine besylate | Marina BioTech | NDA | Current |
| 72931-010 | Prestalia | perindopril arginine and amlodipine besylate | Adhera Therapeutics, Inc. | NDA | Current |
| 72931-011 | Prestalia | perindopril arginine and amlodipine besylate | Adhera Therapeutics, Inc. | NDA | Current |
| 72931-012 | Prestalia | perindopril arginine and amlodipine besylate | Adhera Therapeutics, Inc. | NDA | Current |