Details for New Drug Application (NDA): 021435
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NDA 021435 describes AMVAZ, which is a drug marketed by Dr Reddys Labs Inc and is included in one NDA. Additional details are available on the AMVAZ profile page.
The generic ingredient in AMVAZ is amlodipine maleate. There are fifty drug master file entries for this compound. Additional details are available on the amlodipine maleate profile page.
The generic ingredient in AMVAZ is amlodipine maleate. There are fifty drug master file entries for this compound. Additional details are available on the amlodipine maleate profile page.
Summary for 021435
| Tradename: | AMVAZ |
| Applicant: | Dr Reddys Labs Inc |
| Ingredient: | amlodipine maleate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Oct 31, 2003 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 31, 2003 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 31, 2003 | TE: | RLD: | No | |||||
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