Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Nelco Laboratories, Inc.
054980867
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Nelco Laboratories, Inc.
Nelco Laboratories, Inc.
Nelco Laboratories, Inc.
054980867
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tobacco Leaf
Product Details
NDC Product Code
36987-2238Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Tobacco leafActive
Code: 6YR2608RSUClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Flaxseed
Product Details
NDC Product Code
36987-2214Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Flax seedActive
Code: 4110YT348CClass: ACTIBQuantity: 10000 [PNU] in 1 mL
Jute
Product Details
NDC Product Code
36987-2246Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: TVA75O7S63Class: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Sisal
Product Details
NDC Product Code
36987-2254Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009Agave sisalana fiberActive
Code: MRJ91HVV4HClass: ACTIBQuantity: 10000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT