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-two 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 |
Medical Subject Heading (MeSH) Categories for 050808
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EXTENDED RELEASE;ORAL | Strength | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | 050808-001 | 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 | 050808-005 | Jul 23, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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