SEROMYCIN
Approved
Approval ID
e1e08327-4b90-463e-bb2a-22438cabcef2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
Parsolex Gmp Center, Inc.
DUNS: 159802532
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CYCLOSERINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13845-1200
Application NumberANDA060593
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYCLOSERINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (17)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CYCLOSERINEActive
Quantity: 250 mg in 250 mg
Code: 95IK5KI84Z
Classification: ACTIB
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT