Citalopram Hydrobromide (Page 8 of 8)

CITALOPRAM TABLETS 10 MG

10 MG INDRAD
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10 MG DAHEJ
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CITALOPRAM TABLETS 20 MG

20 MG INDRAD
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20 MG DAHEJ
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CITALOPRAM TABLETS 40 MG

40 MG INDRAD
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40 MG DAHEJ
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CITALOPRAM HYDROBROMIDE citalopram hydrobromide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-009
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE (CITALOPRAM) CITALOPRAM 10 mg
Product Characteristics
Color brown (Tan) Score no score
Shape ROUND (round, biconvex) Size 5mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-009-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-009-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-009-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-009-09 9990 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078216 10/18/2007
CITALOPRAM HYDROBROMIDE citalopram hydrobromide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE (CITALOPRAM) CITALOPRAM 20 mg
Product Characteristics
Color brown (Tan) Score 2 pieces
Shape OVAL (oval, biconvex) Size 9mm
Flavor Imprint Code 2;0;1010
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-010-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-010-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-010-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-010-06 5600 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078216 10/18/2007
CITALOPRAM HYDROBROMIDE citalopram hydrobromide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE (CITALOPRAM) CITALOPRAM 40 mg
Product Characteristics
Color brown (Tin) Score 2 pieces
Shape OVAL (oval,biconvex) Size 11mm
Flavor Imprint Code 4;0;1011
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-011-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-011-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-011-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-011-08 2800 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078216 10/18/2007
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 864147745 analysis (13668-009), analysis (13668-010), analysis (13668-011), manufacture (13668-009), manufacture (13668-010), manufacture (13668-011), pack (13668-009), pack (13668-010), pack (13668-011)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-009), manufacture (13668-010), manufacture (13668-011)

Revised: 09/2023 Torrent Pharmaceuticals Limited

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