Application 215133
- Type
- NDA
- Sponsor
- ALMATICA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZERCAPLI | SERTRALINE HYDROCHORIDE | CAPSULE; ORAL | 150MG | No | No |
| 002 | ZERCAPLI | SERTRALINE HYDROCHORIDE | CAPSULE; ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215133-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, RS | 2021-10-04 |
| N215133-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | RLD | 2021-10-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N215133-001 | AB |
| N215133-002 | AB |
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 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, RS | 2021-10-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | RLD | 2021-10-04 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, RS | 2021-10-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | RLD | 2021-10-04 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, RS | 2021-10-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | RLD | 2021-10-04 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215133-001 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | RLD, RS | 2021-10-04 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215133-002 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | RLD | 2021-10-04 | 6a51e52b5d6a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N215133-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215133-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215133-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215133-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N215133-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215133-002 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215133-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215133-002 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| sertraline hydrochloride | SERTRALINE HYDROCHLORIDE | Alvogen, Inc. | e0e1f35e-114d-bb39-34f1-70208b94ac9e | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | 215133 NDA215133 |
| sertraline HCl | SERTRALINE HYDROCHLORIDE | Almatica Pharma LLC | 8c8bcba9-eaeb-aa44-f9ea-b580de55a439 | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | 215133 NDA215133 52427-672 52427-664 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52427-664 | sertraline HCl | sertraline hydrochloride | Almatica Pharma LLC | NDA | Current |
| 52427-664 | sertraline HCl | sertraline hydrochloride | Almatica Pharma LLC | NDA | Current |
| 52427-672 | sertraline HCl | sertraline hydrochloride | Almatica Pharma LLC | NDA | Current |
| 52427-672 | sertraline HCl | sertraline hydrochloride | Almatica Pharma LLC | NDA | Current |