THEA SINENSIS- thea sinensis pellet 
Hahnemann Laboratories, INC.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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THEA SINENSIS 
thea sinensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1607
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF12 [hp_C]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize3mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1607-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
2NDC:37662-1607-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
3NDC:37662-1607-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/2022
THEA SINENSIS 
thea sinensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1608
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize3mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1608-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
2NDC:37662-1608-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
3NDC:37662-1608-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
4NDC:37662-1608-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/2022
THEA SINENSIS 
thea sinensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1606
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF6 [hp_C]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize3mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1606-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
2NDC:37662-1606-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
3NDC:37662-1606-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/2022
THEA SINENSIS 
thea sinensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1609
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF100 [hp_C]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize2mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1609-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
2NDC:37662-1609-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
3NDC:37662-1609-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
4NDC:37662-1609-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/2022
THEA SINENSIS 
thea sinensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF200 [hp_C]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize2mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1610-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
2NDC:37662-1610-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
3NDC:37662-1610-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
4NDC:37662-1610-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/2022
THEA SINENSIS 
thea sinensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1613
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF1 [hp_Q]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize1mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1613-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/2022
THEA SINENSIS 
thea sinensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1612
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF1 [hp_M]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize2mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1612-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
2NDC:37662-1612-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
3NDC:37662-1612-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
4NDC:37662-1612-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/2022
THEA SINENSIS 
thea sinensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1611
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF500 [hp_C]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize2mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1611-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
2NDC:37662-1611-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
3NDC:37662-1611-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
4NDC:37662-1611-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1606, 37662-1607, 37662-1608, 37662-1609, 37662-1610, 37662-1611, 37662-1612, 37662-1613)

Revised: 9/2022
Document Id: e98d5ff1-ec13-5ad7-e053-2a95a90ad6d0
Set id: e98d5ff1-ec12-5ad7-e053-2a95a90ad6d0
Version: 1
Effective Time: 20220925
 
Hahnemann Laboratories, INC.