DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE CAPSULES - for oral use
Approved
Approval ID
045c1a20-4fe5-49b1-ad43-d92464e42ec7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2020
Manufacturers
FDA
Changzhou Pharmaceutical Factory
DUNS: 653881060
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DOXYCYCLINE HYCLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55488-0186
Application NumberANDA209402
Product Classification
M
Marketing Category
C73584
G
Generic Name
DOXYCYCLINE HYCLATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2020
FDA Product Classification
INGREDIENTS (10)
DOXYCYCLINE HYCLATEActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT