Details for New Drug Application (NDA): 050808
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NDA 050808 describes SOLODYN, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the SOLODYN profile page.
The generic ingredient in SOLODYN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
The generic ingredient in SOLODYN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 050808
| Tradename: | SOLODYN |
| Applicant: | Bausch |
| Ingredient: | minocycline hydrochloride |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 050808
| Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 050808
Suppliers and Packaging for NDA: 050808
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808 | NDA AUTHORIZED GENERIC | Amneal Pharmaceuticals of New York, LLC | 0115-9935 | 0115-9935-08 | 1 BOTTLE in 1 CARTON (0115-9935-08) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808 | NDA AUTHORIZED GENERIC | Amneal Pharmaceuticals of New York, LLC | 0115-9936 | 0115-9936-08 | 1 BOTTLE in 1 CARTON (0115-9936-08) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 8, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 24, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACNE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 7, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACNE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 24, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACNE | ||||||||
Expired US Patents for NDA 050808
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-008 | Aug 27, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-001 | May 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-004 | Jul 23, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-005 | Jul 23, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-006 | Aug 27, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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