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 and is included in two NDAs. It is available from one supplier. 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 |
Pharmacology for NDA: 203540
| Mechanism of Action | HIV Integrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203540
Suppliers and Packaging for NDA: 203540
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RALTEGRAVIR POTASSIUM | raltegravir potassium | TABLET;ORAL | 203540 | ANDA | Camber Pharmaceuticals, Inc. | 31722-584 | 31722-584-60 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-584-60) |
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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