Details for New Drug Application (NDA): 050808
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The generic ingredient in SOLODYN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-four 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 | Bausch Health US LLC | 99207-463 | 99207-463-02 | 10 BOTTLE in 1 CARTON (99207-463-02) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808 | NDA | Bausch Health US LLC | 99207-463 | 99207-463-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-463-30) |
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EXTENDED RELEASE;ORAL | Strength | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | ⤷ Sign Up | Patent Expiration: | Jun 24, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ACNE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 7, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ACNE | ||||||||
Patent: | ⤷ Sign Up | 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 | 050808-003 | May 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-002 | May 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-008 | Aug 27, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-001 | May 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-006 | Aug 27, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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