Application 075520
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
| 002 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 003 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
| 004 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | |
| A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | |
| A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | |
| A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075520-001 | AB |
| A075520-002 | AB |
| A075520-003 | AB |
| A075520-004 | 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 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075520-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-004 | AB | 1 | d06236e962d9… |
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 | Sun Pharmaceutical Industries, Inc. | aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 51672-4003 51672-4004 51672-4001 51672-4002 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Northwind Health Company, LLC | dae3314f-3128-787f-e053-2995a90aff19 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Northwind Health Company, LLC | 09a54dbd-6bde-3083-e063-6394a90a5297 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 51778813-0ec1-6b4f-e054-00144ff8d46c | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 53346b9c-40a1-4b5b-8df0-0b393661fb85 | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 50090-0537 |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | DIRECT RX | 45884cad-4a2d-44f4-93bd-16b130daf32d | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 61919-353 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | cb4d1a69-60ae-4fdc-8af8-059959cf7265 | 2023-10-24 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 70921f99-1f25-4a8c-8269-6d5d26be7a63 | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 63187-715 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 59a65e6f-b812-4195-b85b-c412fb902c93 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 63187-396 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | c5b1ef5e-9681-426a-abf6-60d9c28d92a0 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 63187-798 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43063-897 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-897 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-897 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-897 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-897 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-897 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-897 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-371 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 50090-0507 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0507 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0537 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0537 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0537 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1323 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1323 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-603 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | AvPAK | ANDA | Current |
| 50268-603 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | AvPAK | ANDA | Current |
| 50268-604 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | AvPAK | ANDA | Current |
| 50268-604 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | AvPAK | ANDA | Current |
| 50268-605 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | AvPAK | ANDA | Current |
| 50268-605 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | AvPAK | ANDA | Current |
| 50436-4022 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Unit Dose Services | ANDA | Current |
| 51672-4001 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4001 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4001 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4002 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4002 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4002 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4003 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4003 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4003 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4004 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4004 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4004 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 53217-254 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-501 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-501 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-501 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-501 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Quality Care Products LLC | ANDA | Current |
| 55700-501 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-501 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-501 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-668 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-668 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-668 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-668 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-668 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 58118-4002 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-4002 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-4002 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60687-265 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-265 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-265 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-265 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-281 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-281 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-281 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-281 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-293 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-293 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-293 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-293 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60760-401 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-508 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-811 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-285 | NORTRIPTYLINE HCI | NORTRIPTYLINE HCI | Direct_Rx | ANDA | Current |
| 61919-285 | NORTRIPTYLINE HCI | NORTRIPTYLINE HCI | Direct_Rx | ANDA | Current |
| 61919-285 | NORTRIPTYLINE HCI | NORTRIPTYLINE HCI | Direct_Rx | ANDA | Current |
| 61919-285 | NORTRIPTYLINE HCI | NORTRIPTYLINE HCI | Direct_Rx | ANDA | Current |
| 61919-285 | NORTRIPTYLINE HCI | NORTRIPTYLINE HCI | Direct_Rx | ANDA | Current |
| 61919-353 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-853 | Nortriptyline HCL | Nortriptyline HCL | Direct_Rx | ANDA | Current |
| 61919-853 | Nortriptyline HCL | Nortriptyline HCL | Direct_Rx | ANDA | Current |
| 63187-396 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-396 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-396 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-396 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-715 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-715 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-798 | Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30921 | ORIG | 2000-05-08 |