Solodyn is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Minocycline Hydrochloride.
| Product ID | 99207-463_3c27c96e-5556-4f4e-9971-a3c2d75796c2 |
| NDC | 99207-463 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Solodyn |
| Generic Name | Minocycline Hydrochloride |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2009-07-23 |
| Marketing Category | NDA / NDA |
| Application Number | NDA050808 |
| Labeler Name | Bausch Health US LLC |
| Substance Name | MINOCYCLINE HYDROCHLORIDE |
| Active Ingredient Strength | 65 mg/1 |
| Pharm Classes | Tetracycline-class Drug [EPC],Tetracyclines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2009-07-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA050808 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-07-23 |
| Marketing Category | NDA |
| Application Number | NDA050808 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-07-23 |
| Marketing Category | NDA |
| Application Number | NDA050808 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-07-23 |
| Marketing End Date | 2009-12-15 |
| Marketing Category | NDA |
| Application Number | NDA050808 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-07-23 |
| Marketing End Date | 2016-06-01 |
| Ingredient | Strength |
|---|---|
| MINOCYCLINE HYDROCHLORIDE | 65 mg/1 |
| SPL SET ID: | 1b9dfa57-f295-4038-8aec-8efc54817d07 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 99207-467 | Solodyn | Solodyn |
| 99207-463 | Solodyn | Solodyn |
| 99207-466 | Solodyn | Solodyn |
| 99207-464 | Solodyn | Solodyn |
| 99207-465 | Solodyn | Solodyn |
| 0093-2133 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0093-2134 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0093-7741 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0093-7742 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0093-7743 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0115-9935 | minocycline hydrochloride | minocycline hydrochloride |
| 0115-9936 | minocycline hydrochloride | minocycline hydrochloride |
| 0378-4293 | Minocycline Hydrochloride | minocycline hydrochloride |
| 0378-4294 | Minocycline Hydrochloride | minocycline hydrochloride |
| 0440-7805 | Minocycline hydrochloride | Minocycline hydrochloride |
| 0591-3153 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0591-5694 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0591-5695 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0781-5385 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0781-5386 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0781-5387 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 0904-6888 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 13668-482 | Minocycline Hydrochloride | Minocycline Hydrochloride |
| 10631-330 | Ximino | minocycline hydrochloride |
| 10631-331 | Ximino | minocycline hydrochloride |
| 10631-332 | Ximino | minocycline hydrochloride |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOLODYN 78883462 3332602 Dead/Cancelled |
Medicis Pharmaceutical Corporation 2006-05-15 |
![]() SOLODYN 78595583 3178331 Live/Registered |
Medicis Pharmaceutical Corporation 2005-03-25 |