Application 062031
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
| 002 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062031-001 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | |
| A062031-002 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A062031-001 | AB |
| A062031-002 | 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 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062031-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | Approved before 1982 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062031-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1982-10-13 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A062031-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A062031-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062031-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062031-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062031-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A062031-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062031-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062031-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062031-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062031-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062031-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062031-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062031-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062031-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062031-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062031-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062031-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062031-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062031-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A062031-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062031-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062031-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062031-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062031-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062031-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062031-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062031-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A062031-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062031-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062031-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062031-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A062031-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062031-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A062031-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062031-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A062031-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062031-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A062031-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062031-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A062031-002 | AB | 1 | 782e0a99824c… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-5440 | Doxycycline Hyclate | Doxycycline Hyclate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-5440 | Doxycycline Hyclate | Doxycycline Hyclate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-5440 | Doxycycline Hyclate | Doxycycline Hyclate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-5535 | Doxycycline Hyclate | Doxycycline Hyclate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-5535 | Doxycycline Hyclate | Doxycycline Hyclate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-5535 | Doxycycline Hyclate | Doxycycline Hyclate | Actavis Pharma, Inc. | ANDA | Current |
| 33261-899 | Doxycycline Hyclate | Doxycycline Hyclate | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 51655-184 | Doxycycline Hyclate | Doxycycline Hyclate | Northwind Pharmaceuticals | ANDA | Current |
| 53808-0962 | Doxycycline Hyclate | Doxycycline Hyclate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-2650 | Doxycycline Hyclate | Doxycycline Hyclate | Cardinal Health | ANDA | Current |
| 60687-118 | Doxycycline Hyclate | Doxycycline Hyclate | American Health Packaging | ANDA | Current |
| 60687-118 | Doxycycline Hyclate | Doxycycline Hyclate | American Health Packaging | ANDA | Current |
| 60687-118 | Doxycycline Hyclate | Doxycycline Hyclate | American Health Packaging | ANDA | Current |
| 64725-5440 | Doxycycline Hyclate | Doxycycline Hyclate | TYA Pharmaceuticals | ANDA | Current |
| 71335-0635 | Doxycycline Hyclate | Doxycycline Hyclate | Bryant Ranch Prepack | ANDA | Current |