Details for New Drug Application (NDA): 203540
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NDA 203540 describes RALTEGRAVIR POTASSIUM, which is a drug marketed by Hetero Labs Ltd Iii and Lupin Ltd and is included in two NDAs. Additional details are available on the RALTEGRAVIR POTASSIUM profile page.
The generic ingredient in RALTEGRAVIR POTASSIUM is raltegravir potassium. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
The generic ingredient in RALTEGRAVIR POTASSIUM is raltegravir potassium. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 203540
| Tradename: | RALTEGRAVIR POTASSIUM |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | raltegravir potassium |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 203540
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Dec 19, 2024 | TE: | RLD: | No | |||||
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