Solodyn
These highlights do not include all the information needed to use SOLODYN safely and effectively. See full prescribing information for SOLODYN. SOLODYN (minocycline HCl) Extended Release Tablets for oral use Initial U.S. Approval: 1971
Approved
Approval ID
6ade9be7-f10f-40b2-b5c5-39c5aef3a83d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 4, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
minocycline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6285
Application NumberNDA050808
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2011
FDA Product Classification
INGREDIENTS (9)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
hypromellose 2910 (50 mpa.s)Inactive
Code: 1IVH67816N
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
minocycline hydrochlorideActive
Quantity: 80 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT