Application 078983
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | No | No |
| 002 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 18MG | No | No |
| 003 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | No | No |
| 004 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 40MG | No | No |
| 005 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 60MG | No | No |
| 006 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 80MG | No | No |
| 007 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078983-001 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A078983-002 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A078983-003 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A078983-004 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A078983-005 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A078983-006 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A078983-007 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078983-001 | AB |
| A078983-002 | AB |
| A078983-003 | AB |
| A078983-004 | AB |
| A078983-005 | AB |
| A078983-006 | AB |
| A078983-007 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078983-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078983-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078983-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078983-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078983-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078983-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078983-007 | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-007 | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-007 | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-007 | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-007 | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078983-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078983-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078983-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078983-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078983-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078983-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078983-007 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078983-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078983-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078983-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078983-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078983-005 | AB | 1 | b8a1b40f171c… |
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 |
|---|---|---|---|---|---|---|
| Atomoxetine Hydrochloride | ATOMOXETINE HYDROCHLORIDE | Apotex Corp. | 132852a6-5bff-15dd-255c-98309dd83630 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 078983 ANDA078983 60505-2832 60505-2831 60505-2830 60505-2833 |
| Atomoxetine Hydrochloride | ATOMOXETINE HYDROCHLORIDE | AvPAK | 9e787cc2-5d0f-f231-e053-2a95a90ae99a | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 078983 ANDA078983 50268-057 50268-058 |
| Atomoxetine Hydrochloride | ATOMOXETINE HYDROCHLORIDE | AvPAK | a9df4617-b406-70ba-e053-2995a90a28e8 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | 078983 ANDA078983 50268-059 |
| Atomoxetine Hydrochloride | ATOMOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 6d7ea8f7-981c-4acc-aeaf-7516325bfc0c | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 078983 ANDA078983 |
| Atomoxetine Hydrochloride | ATOMOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 6f14ced9-c16c-905a-e053-2a91aa0a031e | 2025-05-28 | Boxed warning, Warnings, Adverse reactions | 078983 ANDA078983 51407-106 51407-104 51407-101 51407-105 51407-100 51407-103 51407-102 |
| Atomoxetine Hydrochloride | ATOMOXETINE HYDROCHLORIDE | A-S Medication Solutions | 19b10860-aa08-4480-816c-c207819e5f9e | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 078983 ANDA078983 50090-4236 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4235 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4235 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4235 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4235 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4236 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4236 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4236 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4237 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4237 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4237 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4243 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4243 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4243 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4243 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4244 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4244 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4244 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4244 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-057 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | AvPAK | ANDA | Current |
| 50268-057 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | AvPAK | ANDA | Current |
| 50268-057 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | AvPAK | ANDA | Current |
| 50268-058 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | AvPAK | ANDA | Current |
| 50268-058 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | AvPAK | ANDA | Current |
| 50268-058 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | AvPAK | ANDA | Current |
| 50268-059 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | AvPAK | ANDA | Current |
| 51407-100 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-100 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-100 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-100 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-100 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-101 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-101 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-101 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-101 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-101 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-102 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-102 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-102 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-102 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-102 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-103 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-103 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-103 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-103 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-103 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-104 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-104 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-104 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-104 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-104 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-105 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-105 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-105 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-105 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-105 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-106 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-106 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-106 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-106 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-106 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60505-2830 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2830 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2830 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2830 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2830 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2830 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2831 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2831 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2831 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2831 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2831 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2831 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2832 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2832 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2832 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2832 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2832 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2832 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2833 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2833 | Atomoxetine Hydrochloride | atomoxetine hydrochloride | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48629 | ORIG | 2017-06-02 |