Application 050649
- Type
- NDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | Yes | No |
| 002 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE | Yes | No |
| 003 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050649-001 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 |
| N050649-002 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 |
| N050649-003 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050649-001 | AB |
| N050649-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050649-002 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050649-001 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD | 1990-05-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050649-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050649-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N050649-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050649-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N050649-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050649-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050649-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050649-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050649-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050649-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050649-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050649-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050649-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050649-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050649-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050649-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050649-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050649-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050649-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050649-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050649-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050649-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050649-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050649-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050649-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050649-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050649-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050649-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050649-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050649-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050649-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050649-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050649-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050649-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050649-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050649-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050649-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050649-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050649-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050649-002 | AB | 1 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 100b48e9-0884-4112-b9aa-cb6f07c28756 | 2025-07-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | dddad9bc-a0a3-41bf-81e5-65d9903b14c6 | 2025-07-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | fb4deae8-23f0-42dd-ac2e-b69ab39a6c4d | 2025-07-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | a0f88292-680b-4d50-ae6e-0a7bccc3a9c6 | 2025-07-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Chartwell RX, LLC | 43fbe7ff-4b67-474d-bf27-e5710d8d10ac | 2025-06-17 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| minocycline hydrochloride | MINOCYCLINE HYDROCHLORIDE | Zydus Lifesciences Limited | 8bf9cf23-8ffc-401f-981d-4878d694a468 | 2025-06-05 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| minocycline hydrochloride | MINOCYCLINE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 85f082a5-bba1-4441-ba28-4b8ec9a537f2 | 2025-06-05 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Actavis Pharma, Inc. | a5fc4d50-50b2-46e0-b722-4c6b2ec47d06 | 2025-06-01 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ec93ad27-aff5-cbc7-e053-2a95a90adc7e | 2025-05-07 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline hydrochloride | MINOCYCLINE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 25acb785-6838-4e62-9e86-ddc30b2b759a | 2025-04-26 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Aurobindo Pharma Limited | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 2025-04-11 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Aurobindo Pharma Limited | 9013ca48-15f2-43cd-a51d-91cf65c72a7c | 2025-04-08 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | d00d9bc4-c764-4ec1-beb0-44668637bcfb | 2025-01-28 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1c363cbb-099b-7c73-e063-6394a90ae13f | 2025-01-02 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Aurobindo Pharma Limited | 799a9871-3249-471e-b88d-5d8f7d4b96ad | 2025-01-01 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline hydrochloride | MINOCYCLINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f901a1ba-1716-8795-e053-6294a90a4e77 | 2024-12-31 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | a6224eeb-25be-4f1d-889f-809aaf338c8c | 2024-10-07 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline hydrochloride | MINOCYCLINE HYDROCHLORIDE | Zydus Lifesciences Limited | 26ee99af-f44b-4076-a08c-0a0dedc9edfe | 2024-10-03 | MINOCYCLINE HYDROCHLORIDE | |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6f154720-706e-4177-8167-1bc893303f1b | 2024-09-04 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | abaacdeb-2433-261a-e053-2995a90ae34e | 2024-07-17 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 16781-400 | Minocin | minocycline hydrochloride | Onset Dermatologics LLC | NDA | Current |
| 16781-400 | Minocin | minocycline hydrochloride | Bausch Health US, LLC | NDA | Current |
| 16781-403 | Minocin | minocycline hydrochloride | Onset Dermatologics LLC | NDA | Current |
| 16781-403 | Minocin | minocycline hydrochloride | Bausch Health US, LLC | NDA | Current |
| 43353-172 | Minocin | minocycline hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81853 | SUPPL | 2025-04-08 |
| 81793 | SUPPL | 2025-04-02 |
| 79144 | SUPPL | 2024-07-22 |
| 79129 | SUPPL | 2024-07-22 |
| 49037 | SUPPL | 2017-07-21 |
| 49025 | SUPPL | 2017-07-20 |
| 46175 | SUPPL | 2016-12-15 |
| 46189 | SUPPL | 2016-12-14 |
| 39073 | SUPPL | 2015-03-26 |
| 30224 | SUPPL | 2015-03-11 |
| 17973 | SUPPL | 2010-09-20 |
| 30223 | SUPPL | 2010-09-17 |
| 7935 | SUPPL | 2008-07-01 |
| 39072 | SUPPL | 2008-06-30 |
| 30222 | SUPPL | 2007-06-04 |
| 7933 | SUPPL | 2007-04-09 |
| 17972 | SUPPL | 2007-04-06 |
| 7934 | SUPPL | 2007-02-02 |
| 39071 | SUPPL | 2007-01-25 |
| 7932 | SUPPL | 2005-10-20 |
| 30220 | SUPPL | 2005-02-17 |
| 42664 | SUPPL | 2004-06-29 |
| 30221 | SUPPL | 2004-06-01 |
| 7931 | SUPPL | 2004-06-01 |
| 7930 | SUPPL | 2002-05-31 |
| 7929 | SUPPL | 2002-02-01 |
| 7928 | SUPPL | 2002-02-01 |