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FDA Approval

Cotton

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Nelco Laboratories, Inc.
DUNS: 054980867
Effective Date
December 11, 2009
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Orris(0.05 g in 1 mL)

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

Products8

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Orris Root

Product Details

NDC Product Code
36987-2235
Application Number
BLA102192
Marketing Category
BLA (C73585)
Route of Administration
INTRADERMAL, SUBCUTANEOUS
Effective Date
December 11, 2009
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
OrrisActive
Code: M30XO5X4XDClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Flaxseed

Product Details

NDC Product Code
36987-2219
Application Number
BLA102192
Marketing Category
BLA (C73585)
Route of Administration
INTRADERMAL, SUBCUTANEOUS
Effective Date
December 11, 2009
Flax seedActive
Code: 4110YT348CClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Jute

Product Details

NDC Product Code
36987-2251
Application Number
BLA102192
Marketing Category
BLA (C73585)
Route of Administration
INTRADERMAL, SUBCUTANEOUS
Effective Date
December 11, 2009
Corcorus capsularis fiberActive
Code: TVA75O7S63Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Sisal

Product Details

NDC Product Code
36987-2259
Application Number
BLA102192
Marketing Category
BLA (C73585)
Route of Administration
INTRADERMAL, SUBCUTANEOUS
Effective Date
December 11, 2009
Agave sisalana fiberActive
Code: MRJ91HVV4HClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Kapok

Product Details

NDC Product Code
36987-2227
Application Number
BLA102192
Marketing Category
BLA (C73585)
Route of Administration
INTRADERMAL, SUBCUTANEOUS
Effective Date
December 11, 2009
Ceiba pentandra fiberActive
Code: 758Z9H9WV9Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT

Cotton

Product Details

NDC Product Code
36987-2195
Application Number
BLA102192
Marketing Category
BLA (C73585)
Route of Administration
INTRADERMAL, SUBCUTANEOUS
Effective Date
December 11, 2009
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CottonActive
Code: 7S4U9R5259Class: ACTIBQuantity: 0.05 g in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Cotton Seed

Product Details

NDC Product Code
36987-2211
Application Number
BLA102192
Marketing Category
BLA (C73585)
Route of Administration
INTRADERMAL, SUBCUTANEOUS
Effective Date
December 11, 2009
Cotton seedActive
Code: DI0ZRJ0MXNClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Cotton Linters

Product Details

NDC Product Code
36987-2203
Application Number
BLA102192
Marketing Category
BLA (C73585)
Route of Administration
INTRADERMAL, SUBCUTANEOUS
Effective Date
December 11, 2009
CottonActive
Code: 70LDW53ROOClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
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