Details for New Drug Application (NDA): 077038
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NDA 077038 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Almatica, Norvium Bioscience, Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Pharm Assoc, Biovail Labs Intl, Amneal Pharms Ny, Apotex, Aurobindo, Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Fosun Pharma, Glenmark Pharms Ltd, Heritage Pharma, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Roxane, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, and Torrent Pharms, and is included in thirty-four NDAs. It is available from forty-three 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-four 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-four suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 077038
| Tradename: | CITALOPRAM HYDROBROMIDE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | citalopram hydrobromide |
| Patents: | 0 |
Pharmacology for NDA: 077038
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 077038
Suppliers and Packaging for NDA: 077038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | TABLET;ORAL | 077038 | ANDA | International Laboratories, LLC | 54458-889 | 54458-889-10 | 30 TABLET, FILM COATED in 1 BLISTER PACK (54458-889-10) |
| CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | TABLET;ORAL | 077038 | ANDA | International Laboratories, LLC | 54458-889 | 54458-889-16 | 30 TABLET, FILM COATED in 1 BOTTLE (54458-889-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Oct 28, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Oct 28, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Oct 28, 2004 | TE: | AB | RLD: | No | ||||
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