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
Products9
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Jute
Product Details
NDC Product Code
36987-2252Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009Code: TVA75O7S63Class: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Tobacco Leaf
Product Details
NDC Product Code
36987-2244Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009WATERInactive
Code: 059QF0KO0RClass: IACT
Tobacco leafActive
Code: 6YR2608RSUClass: ACTIBQuantity: 0.025 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Sisal
Product Details
NDC Product Code
36987-2260Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009Agave sisalana fiberActive
Code: MRJ91HVV4HClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Orris Root
Product Details
NDC Product Code
36987-2236Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009OrrisActive
Code: M30XO5X4XDClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Cotton Seed
Product Details
NDC Product Code
36987-2212Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Cotton seedActive
Code: DI0ZRJ0MXNClass: ACTIBQuantity: 0.1 g in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Cotton Linters
Product Details
NDC Product Code
36987-2204Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CottonActive
Code: 70LDW53ROOClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Flaxseed
Product Details
NDC Product Code
36987-2220Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009Flax seedActive
Code: 4110YT348CClass: ACTIBQuantity: 0.1 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Kapok
Product Details
NDC Product Code
36987-2228Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Ceiba pentandra fiberActive
Code: 758Z9H9WV9Class: ACTIBQuantity: 0.1 g in 1 mL
Cotton
Product Details
NDC Product Code
36987-2196Application Number
BLA102192Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
December 11, 2009CottonActive
Code: 7S4U9R5259Class: ACTIBQuantity: 0.1 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT