Minocycline Hydrochloride
MinocyclineHydrochlorideCapsules USP Revised: July 2014 Rx only
Approved
Approval ID
36120c7e-69b3-40c1-b37d-a4d3a3ccee7c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2016
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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
NDC Product Code43353-105
Application NumberANDA063065
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 22, 2014
Generic NameMinocycline Hydrochloride
INGREDIENTS (10)
MINOCYCLINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT