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Details for New Drug Application (NDA): 077032
» See Plans and Pricing
NDA 077032 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Mylan Pharms Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Hikma, Lannett Co Inc, Pharm Assoc, Biovail Labs Intl, Amneal Pharms Ny, Apotex Inc, Aurobindo, Chartwell Molecular, Cosette, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Fosun Pharma, Glenmark Generics, Heritage Pharma, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Roxane, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, Torpharm, and Torrent Pharms, and is included in thirty-three NDAs. It is available from forty-four suppliers. Additional details are available on the CITALOPRAM HYDROBROMIDE profile page.
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.
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 077032
| Tradename: | CITALOPRAM HYDROBROMIDE |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | citalopram hydrobromide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077032
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 077032
Suppliers and Packaging for NDA: 077032
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | TABLET;ORAL | 077032 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-507 | 57664-507-13 | 500 TABLET in 1 BOTTLE (57664-507-13) |
| CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | TABLET;ORAL | 077032 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-507 | 57664-507-88 | 100 TABLET in 1 BOTTLE (57664-507-88) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Nov 12, 2004 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Nov 12, 2004 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Nov 12, 2004 | TE: | RLD: | No | |||||
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