Application 079019
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
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 |
|---|---|---|---|---|---|---|---|
| A079019-001 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A079019-002 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A079019-003 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A079019-004 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A079019-005 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A079019-006 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | |
| A079019-007 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079019-001 | AB |
| A079019-002 | AB |
| A079019-003 | AB |
| A079019-004 | AB |
| A079019-005 | AB |
| A079019-006 | AB |
| A079019-007 | 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 | A079019-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079019-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079019-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079019-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079019-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079019-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079019-007 | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-007 | 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 | A079019-001 | 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 | A079019-002 | 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 | A079019-003 | 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 | A079019-004 | 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 | A079019-005 | 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 | A079019-006 | 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 | A079019-007 | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-007 | 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 | A079019-001 | 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 | A079019-002 | 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 | A079019-003 | 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 | A079019-004 | 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 | A079019-005 | 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 | A079019-006 | 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 | A079019-007 | 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 | A079019-001 | 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 | A079019-002 | 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 | A079019-003 | 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 | A079019-004 | 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 | A079019-005 | 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 | A079019-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079019-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079019-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079019-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079019-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079019-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079019-007 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079019-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079019-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079019-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079019-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079019-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079019-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079019-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079019-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079019-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079019-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079019-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079019-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079019-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079019-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079019-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079019-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079019-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079019-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079019-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079019-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079019-005 | 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 | ATOMOXETINE | Bryant Ranch Prepack | 97a4aa63-0877-40e5-94c4-ea487db5691d | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 079019 ANDA079019 |
| atomoxetine | ATOMOXETINE | A-S Medication Solutions | 90f45a1e-f79f-468f-b21b-5dc82f5717aa | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | 079019 ANDA079019 |
| atomoxetine | ATOMOXETINE | Northstar Rx LLC | 133a4b65-762b-4712-baba-2442546f0379 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 079019 ANDA079019 16714-755 16714-757 16714-758 16714-760 16714-756 16714-761 16714-759 |
| atomoxetine | ATOMOXETINE | Glenmark Pharmaceuticals Inc., USA | 0ab8d905-e890-4e91-a730-3e5d12f5c23f | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 079019 ANDA079019 68462-270 68462-269 68462-268 68462-266 68462-271 68462-267 68462-265 |
| atomoxetine | ATOMOXETINE | A-S Medication Solutions | f75bc8e2-8e8e-4883-be9c-b716842c5277 | 2024-11-21 | Boxed warning, Warnings, Adverse reactions | 079019 ANDA079019 |
| atomoxetine | ATOMOXETINE | A-S Medication Solutions | 793928fb-fbcb-4fc6-90d4-f8a15e6b1f93 | 2024-10-25 | Boxed warning, Warnings, Adverse reactions | 079019 ANDA079019 |
| atomoxetine | ATOMOXETINE | A-S Medication Solutions | 47f6faeb-52b5-4b04-bf34-de5db8eb46dc | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 079019 ANDA079019 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-755 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-755 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-755 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-755 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-756 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-756 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-756 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-756 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-757 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-757 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-757 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-757 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-758 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-758 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-758 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-758 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-759 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-759 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-759 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-759 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-760 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-760 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-760 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-760 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-761 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-761 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-761 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 16714-761 | atomoxetine | atomoxetine | Northstar Rx LLC | ANDA | Current |
| 68462-265 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-265 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-265 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-265 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-265 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-266 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-266 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-266 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-266 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-266 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-267 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-267 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-267 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-267 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-267 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-268 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-268 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-268 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-268 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-268 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-269 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-269 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-269 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-269 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-269 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-270 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-270 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-270 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-270 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-270 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-271 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-271 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-271 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-271 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-271 | atomoxetine | atomoxetine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 70518-2474 | atomoxetine | atomoxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2474 | atomoxetine | atomoxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2474 | atomoxetine | atomoxetine | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48631 | ORIG | 2017-06-02 |