Application 210268
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
| 003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
| 004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210268-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | |
| A210268-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | |
| A210268-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | |
| A210268-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | |
| A210268-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210268-001 | AB |
| A210268-002 | AB |
| A210268-003 | AB |
| A210268-004 | AB |
| A210268-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210268-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210268-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210268-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210268-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210268-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210268-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210268-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210268-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210268-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210268-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210268-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210268-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210268-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210268-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210268-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210268-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210268-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210268-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210268-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210268-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210268-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210268-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210268-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210268-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210268-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210268-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210268-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210268-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210268-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210268-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210268-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210268-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210268-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210268-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210268-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210268-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210268-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210268-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210268-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210268-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-09-04 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210268-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210268-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210268-003 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210268-004 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210268-005 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210268-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210268-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210268-003 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210268-004 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210268-005 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A210268-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A210268-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A210268-003 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A210268-004 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A210268-005 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A210268-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A210268-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A210268-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A210268-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A210268-005 | AB | 1 | 3bdfa0b2c4d7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210268-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210268-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210268-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210268-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210268-005 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Chartwell RX, LLC | 33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 210268 ANDA210268 62135-564 62135-562 62135-563 62135-561 62135-560 |
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 |
|---|---|---|---|---|---|
| 62135-560 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-561 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-562 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-563 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-564 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |