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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050808
Company: BAUSCH

Products on NDA 050808

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050808

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050808lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050808s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050808s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2025	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050808s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050808Orig1s028ltr.pdf
03/18/2025	SUPPL-27	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050808s024s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050808Orig1s024, s027ltr.pdf
03/18/2025	SUPPL-24	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050808s024s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050808Orig1s024, s027ltr.pdf
10/21/2013	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050808s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050808Orig1s023ltr.pdf
07/15/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/17/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/03/2016	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
04/20/2011	SUPPL-15	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s015ltr.pdf
03/18/2011	SUPPL-14	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050808Orig1s014.pdf
08/07/2010	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050808s013lbl.pdf
12/30/2009	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s011ltr.pdf
07/23/2009	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s007ltr.pdf
02/27/2007	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 050808

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2025	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050808s028lbl.pdf
03/18/2025	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050808s024s027lbl.pdf
03/18/2025	SUPPL-27	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050808s024s027lbl.pdf
03/18/2025	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050808s024s027lbl.pdf
03/18/2025	SUPPL-24	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050808s024s027lbl.pdf
10/21/2013	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050808s023lbl.pdf
03/18/2011	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf
08/07/2010	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050808s013lbl.pdf
12/30/2009	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf
07/23/2009	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf
07/23/2009	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf
05/08/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050808lbl.pdf

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