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HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 |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| 2026-08 | N050649-003 | MINOCIN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-02-12 | 84e616aacf4f… | |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 | 99825095-d897-4077-86df-483d505615b2 | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 493bdeac-e073-4ec2-a481-85e6a6d3cb58 | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 74946a91-b138-42cd-a9d4-58fe8f849270 | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 653b22f3-9eb5-4c29-9b95-bc1c4f0273be | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | e1611d28-0c96-4ce2-ad5d-f62f66ec164d | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | bb3b9a7e-6724-4c2a-b3cb-236f522b31a8 | 2026-03-09 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | A-S Medication Solutions | c96b1c5d-7004-4ee2-ad48-0ba963389f86 | 2026-02-19 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | REMEDYREPACK INC. | 6597bdc9-9e3a-4c11-8b39-27b47f863287 | 2026-02-04 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline hydrochloride | MINOCYCLINE HYDROCHLORIDE | Northwind Health Company, LLC | 0760232b-21a6-2b13-e063-6394a90a22c1 | 2026-01-01 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Northwind Health Company, LLC | 12559b29-6568-4b99-a16e-6a87038981f7 | 2026-01-01 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline hydrochloride | MINOCYCLINE HYDROCHLORIDE | Northwind Health Company, LLC | f33fcfd2-b9ef-8e67-e053-2a95a90a0306 | 2026-01-01 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Ascend Laboratories, LLC | a8f95207-b259-4f50-87f2-3652d9268890 | 2025-12-18 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6b2a7493-2e6c-4901-b697-17eb188cc8dd | 2025-11-17 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocin | MINOCYCLINE HYDROCHLORIDE | Melinta Therapeutics, LLC | e415c323-8219-464b-9e3e-72c5a796cdaa | 2025-09-11 | Warnings, Adverse reactions | Minocin MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | e69284bc-0479-48d0-beb5-a26cfad6cd76 | 2025-08-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 2688e63a-09c7-4d73-a923-cf14fec7b1a4 | 2025-07-28 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | ddd22f2c-050b-4776-912b-39b3e6202c75 | 2025-07-28 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | American Health Packaging | 94d941e3-d3d8-4414-bd5c-4a92848e738f | 2025-07-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 9f4139e4-d4ab-46ea-a3f1-f719ab57a55e | 2025-07-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 084fb405-fcb9-4db9-8d95-5a9c1d89f3b6 | 2025-07-03 | 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 |