Details for New Drug Application (NDA): 201450
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The generic ingredient in CITALOPRAM HYDROBROMIDE is citalopram hydrobromide. There are fifty-six drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 201450
Tradename: | CITALOPRAM HYDROBROMIDE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | citalopram hydrobromide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201450
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 201450
Suppliers and Packaging for NDA: 201450
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | SOLUTION;ORAL | 201450 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0564 | 17856-0564-1 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0564-1) / 10 mL in 1 CUP, UNIT-DOSE |
CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | SOLUTION;ORAL | 201450 | ANDA | Camber Pharmaceuticals, Inc. | 31722-564 | 31722-564-24 | 240 mL in 1 BOTTLE (31722-564-24) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 10MG BASE/5ML | ||||
Approval Date: | Dec 15, 2015 | TE: | AA | RLD: | No |
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