Application 090422
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 45MG BASE | No | No |
| 002 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 90MG BASE | No | No |
| 003 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 135MG BASE | No | Yes |
| 004 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | EQ 65MG BASE | No | No |
| 005 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | EQ 115MG BASE | No | No |
| 006 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | EQ 55MG BASE | No | No |
| 007 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | Tablet, Extended Release; Oral | EQ 80MG BASE | No | No |
| 008 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | Tablet, Extended Release; Oral | EQ 105MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090422-001 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | |
| A090422-002 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | |
| A090422-003 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090422-001 | AB |
| A090422-002 | AB |
| A090422-003 | 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 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2009-08-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090422-002 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090422-003 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2009-08-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090422-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-13 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090422-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090422-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090422-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090422-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090422-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090422-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090422-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090422-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090422-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090422-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090422-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090422-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090422-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090422-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090422-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090422-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090422-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090422-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090422-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090422-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090422-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090422-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090422-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090422-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090422-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090422-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090422-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090422-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090422-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090422-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090422-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090422-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090422-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090422-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090422-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090422-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090422-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090422-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090422-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090422-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|
| 0781-5385 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5385 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5386 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5386 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5387 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5387 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |