Okebo
Okebo™ (Doxycycline monohydrate USP) Capsules 50 mg, 75 mg and 100 mg Rx only
Approved
Approval ID
5e351090-afed-425b-e053-2a91aa0a206d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2020
Manufacturers
FDA
Encore Dermatology Inc.
DUNS: 079629654
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69482-475
Application NumberANDA204234
Product Classification
M
Marketing Category
C73584
G
Generic Name
doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2017
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DOXYCYCLINEActive
Quantity: 75 mg in 1 1
Code: N12000U13O
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT