Application 079021
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
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 |
|---|---|---|---|---|---|---|---|
| A079021-001 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | |
| A079021-002 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | |
| A079021-003 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | |
| A079021-004 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | |
| A079021-005 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | |
| A079021-006 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | |
| A079021-007 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-02-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079021-001 | AB |
| A079021-002 | AB |
| A079021-003 | AB |
| A079021-004 | AB |
| A079021-005 | AB |
| A079021-006 | AB |
| A079021-007 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A079021-001 | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A079021-002 | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A079021-003 | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A079021-004 | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A079021-005 | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A079021-006 | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A079021-007 | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-02-18 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A079021-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A079021-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A079021-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A079021-004 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A079021-005 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A079021-006 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A079021-007 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Atomoxetine | ATOMOXETINE | Bryant Ranch Prepack | 47cd1d85-fbc1-4309-9365-58bacf108f5b | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |
| Atomoxetine | ATOMOXETINE | Bryant Ranch Prepack | b00eb367-d7cc-42fa-91af-a1a5f90dbb41 | 2025-12-03 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |
| Atomoxetine | ATOMOXETINE | Bryant Ranch Prepack | bb2c12e4-563c-417e-bee1-6d8c51e75af4 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |
| Atomoxetine | ATOMOXETINE | Bryant Ranch Prepack | c5e9e305-8d99-4234-b531-6ade177768b7 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |
| Atomoxetine | ATOMOXETINE | Bryant Ranch Prepack | 1d26aff3-72a7-4a5b-a6fe-44dc8a08b196 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |
| Atomoxetine | ATOMOXETINE | Bryant Ranch Prepack | 9c1f858c-8721-49e3-be8b-bf180e89ff42 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |
| Atomoxetine | ATOMOXETINE | Bryant Ranch Prepack | bbb2a8f6-0816-47b1-830a-ef23e97d498f | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |
| Atomoxetine | ATOMOXETINE | Bryant Ranch Prepack | c6542d69-d0a2-4663-9172-943f9f6f5325 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |
| Atomoxetine | ATOMOXETINE | Strides Pharma Science Limited | 2614df7e-0b16-4b03-883e-141d4ec34b35 | 2025-08-10 | Boxed warning, Warnings, Adverse reactions | 079021 ANDA079021 |