Application 213441
- Type
- ANDA
- Sponsor
- ZYDUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 002 | 0 | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | No | No | |
| 003 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
| 004 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213441-001 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2021-02-24 | ||
| A213441-002 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2021-02-24 | ||
| A213441-003 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2021-02-24 | ||
| A213441-004 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2021-02-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-05-13 08:27 UTC | 2023-05 | A213441-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2021-02-24 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213441-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2021-02-24 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213441-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2021-02-24 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213441-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2021-02-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213441-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2021-02-24 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213441-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2021-02-24 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213441-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2021-02-24 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213441-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2021-02-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213441-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2021-02-24 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213441-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2021-02-24 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213441-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2021-02-24 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213441-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2021-02-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213441-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2021-02-24 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213441-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2021-02-24 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213441-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2021-02-24 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213441-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2021-02-24 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213441-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2021-02-24 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213441-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2021-02-24 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213441-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2021-02-24 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213441-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2021-02-24 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213441-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2021-02-24 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213441-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2021-02-24 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213441-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2021-02-24 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213441-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2021-02-24 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213441-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2021-02-24 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213441-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2021-02-24 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213441-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2021-02-24 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213441-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2021-02-24 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213441-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213441-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213441-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213441-004 | AB | 1 | 87673890dc5c… |
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 |
|---|---|---|---|---|---|---|
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Zydus Lifesciences Limited | f22dce73-b895-4fe2-8cf7-816dca93c246 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | 213441 ANDA213441 70771-1612 70771-1614 70771-1615 70771-1613 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | dbe85bdc-17a1-4201-bf48-a52e35d69b68 | 2024-03-27 | Boxed warning, Warnings, Adverse reactions | 213441 ANDA213441 70710-1156 70710-1153 70710-1154 70710-1155 |
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 |
|---|---|---|---|---|---|
| 70710-1153 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1154 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1155 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1156 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1612 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1613 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1614 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1615 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |