Application 202261
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 65MG BASE | No | No |
| 003 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 90MG BASE | No | No |
| 004 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 115MG BASE | No | No |
| 005 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 135MG BASE | No | No |
| 006 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 80MG BASE | No | No |
| 007 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 105MG BASE | No | No |
| 008 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 55MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202261-001 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | |
| A202261-002 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | |
| A202261-003 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | |
| A202261-004 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | |
| A202261-005 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | |
| A202261-006 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | |
| A202261-007 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | |
| A202261-008 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-08-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202261-001 | AB |
| A202261-002 | AB |
| A202261-003 | AB |
| A202261-004 | AB |
| A202261-005 | AB |
| A202261-006 | AB |
| A202261-007 | AB |
| A202261-008 | 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 | A202261-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-002 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-004 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-006 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-007 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-08-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-002 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-004 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-006 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-007 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-08-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-002 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-004 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-006 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-007 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-08-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-002 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-004 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-006 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-007 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-08-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-002 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-004 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-006 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-007 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-08-21 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202261-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202261-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202261-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202261-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202261-008 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202261-008 | AB | 1 | b8a1b40f171c… |
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 | Aurobindo Pharma Limited | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 2025-04-11 | Warnings, Adverse reactions | 202261 ANDA202261 65862-555 65862-554 65862-557 65862-884 65862-883 65862-885 65862-556 65862-558 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-102 | Minocycline Hydrochloride | Minocycline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-103 | Minocycline Hydrochloride | Minocycline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-104 | Minocycline Hydrochloride | Minocycline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-105 | Minocycline Hydrochloride | Minocycline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-106 | Minocycline Hydrochloride | Minocycline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-107 | Minocycline Hydrochloride | Minocycline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-108 | Minocycline Hydrochloride | Minocycline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-109 | Minocycline Hydrochloride | Minocycline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 42546-771 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-771 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-771 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-771 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-774 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-774 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-774 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-774 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-777 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-777 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-777 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 42546-777 | Minocycline Hydrochloride | Minocycline Hydrochloride | PruGen Pharmaceuticals | ANDA | Current |
| 65862-554 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-554 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-554 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-554 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-555 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-555 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-555 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-555 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-556 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-556 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-556 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-556 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-557 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-557 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-557 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-557 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-558 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-558 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-558 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-558 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-883 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-883 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-883 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-884 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-884 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-884 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-884 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-885 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-885 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-885 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-885 | Minocycline Hydrochloride | Minocycline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55945 | ORIG | 2018-10-15 |