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Details for New Drug Application (NDA): 077032
NDA 077032 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Mylan Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Silarx, West-ward Pharms Int, Biovail Labs Intl, Actavis Elizabeth, Amneal Pharms Ny, Aurobindo, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Fosun Pharma, G And W Labs Inc, Glenmark Generics, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Pliva, Roxane, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, Teva Pharms, Torpharm, Torrent Pharms, and Watson Labs, and is included in thirty-three NDAs. It is available from fifty-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. Fifty-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. Fifty-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 |
| Therapeutic Class: | Antidepressants |
| 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 | PD-Rx Pharmaceuticals, Inc. | 43063-221 | N | 43063-221-30 |
| CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | TABLET;ORAL | 077032 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-249 | N | 43063-249-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Nov 12, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Nov 12, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Nov 12, 2004 | TE: | AB | RLD: | No | ||||
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