Application 050315
- Type
- NDA
- Sponsor
- TRIAX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
| 002 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| N050315-001 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | ||
| N050315-002 | MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050315-001 | MINOCIN | EQ 100MG BASE | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050315-002 | MINOCIN | EQ 50MG BASE | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… |
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 | PD-Rx Pharmaceuticals, Inc. | 3e74e8a3-2670-97f5-e063-6394a90a361e | 2026-08-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3e796794-b731-61d6-e063-6394a90aa9b3 | 2026-07-31 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Major Pharamceuticals | fd86ff45-37d0-4501-b9fb-e1836e4a8be4 | 2026-07-16 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | caa99901-467c-4e99-b7e9-fbabdf5d118c | 2026-07-08 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | REMEDYREPACK INC. | 0becbde8-6ec5-4830-a0d9-cfdb7b15eb84 | 2026-07-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 093ff3c7-3ecc-47b4-9ae6-5218bcd262b2 | 2026-06-26 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 65767ae3-b1ed-4492-90f2-703b2c7e0f38 | 2026-06-24 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 87a137c6-dd53-44d3-ab49-ef78ebed35c8 | 2026-06-12 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1ec20539-0421-4eac-95ed-e9acc6329fd0 | 2026-06-12 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7e2390b7-242c-43ff-afb3-b0a5e79351d3 | 2026-05-13 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | c11bfea8-6079-44ce-b8e1-20bfba631bec | 2026-05-04 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6e0efd1a-5a09-4030-8fe2-f98334cdeb0e | 2026-04-22 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 9c43389b-dc98-41f3-80bf-73d916ad6843 | 2026-04-22 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | A-S Medication Solutions | c7d0226e-5ac5-4fb1-9849-9d6663a2e8ad | 2026-04-17 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | bae17358-1180-4ca8-b163-f9a6f4f83a3d | 2026-04-09 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | 3539f84e-b489-4914-96c1-ac3731032971 | 2026-04-08 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | 55df55fb-18ec-4e00-9ed0-10bba0da513b | 2026-04-02 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 409dddb0-be3a-4ae3-ab39-88a6cd50a219 | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | b3236a5c-8a5d-4d5d-9656-aee72a4c482b | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | a16012ce-5754-4177-bfb7-dcce696a7189 | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.