Details for New Drug Application (NDA): 040829
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NDA 040829 describes CHLORPHENIRAMINE MALEATE, which is a drug marketed by Aurolife Pharma Llc, Bel Mar, Elkins Sinn, Watson Labs, Pharm Assoc, Avanthi Inc, Anabolic, Bell Pharma, Impax Labs, Ivax Sub Teva Pharms, Kv Pharm, Lederle, Newtron Pharms, Panray, Pharmavite, Pharmeral, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Vitarine, and West Ward, and is included in thirty NDAs. It is available from two suppliers. Additional details are available on the CHLORPHENIRAMINE MALEATE profile page.
The generic ingredient in CHLORPHENIRAMINE MALEATE is chlorpheniramine maleate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.
The generic ingredient in CHLORPHENIRAMINE MALEATE is chlorpheniramine maleate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.
Summary for 040829
| Tradename: | CHLORPHENIRAMINE MALEATE |
| Applicant: | Avanthi Inc |
| Ingredient: | chlorpheniramine maleate |
| Patents: | 0 |
Pharmacology for NDA: 040829
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 040829
Suppliers and Packaging for NDA: 040829
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORPHENIRAMINE MALEATE | chlorpheniramine maleate | TABLET, EXTENDED RELEASE;ORAL | 040829 | ANDA | KVK-Tech, Inc. | 10702-017 | 10702-017-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-01) |
| CHLORPHENIRAMINE MALEATE | chlorpheniramine maleate | TABLET, EXTENDED RELEASE;ORAL | 040829 | ANDA | KVK-Tech, Inc. | 10702-017 | 10702-017-06 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 12MG | ||||
| Approval Date: | May 13, 2009 | TE: | RLD: | No | |||||
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