Details for New Drug Application (NDA): 215636
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NDA 215636 describes METHYLENE BLUE, which is a drug marketed by Chengdu Shuode, Hikma, Meitheal, Nexus, Steriscience, Xiromed, and Zydus Lifesciences, and is included in seven NDAs. It is available from eleven suppliers. Additional details are available on the METHYLENE BLUE profile page.
The generic ingredient in METHYLENE BLUE is methylene blue. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methylene blue profile page.
The generic ingredient in METHYLENE BLUE is methylene blue. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methylene blue profile page.
Summary for 215636
| Tradename: | METHYLENE BLUE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | methylene blue |
| Patents: | 0 |
Pharmacology for NDA: 215636
| Mechanism of Action | Oxidation-Reduction Activity |
Medical Subject Heading (MeSH) Categories for 215636
Suppliers and Packaging for NDA: 215636
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLENE BLUE | methylene blue | SOLUTION;INTRAVENOUS | 215636 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1837 | 70710-1837-5 | 5 VIAL in 1 CARTON (70710-1837-5) / 2 mL in 1 VIAL (70710-1837-1) |
| METHYLENE BLUE | methylene blue | SOLUTION;INTRAVENOUS | 215636 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1838 | 70710-1838-5 | 5 VIAL in 1 CARTON (70710-1838-5) / 10 mL in 1 VIAL (70710-1838-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/2ML (5MG/ML) | ||||
| Approval Date: | Dec 5, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/10ML (5MG/ML) | ||||
| Approval Date: | Dec 5, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5MG/ML (5MG/ML) | ||||
| Approval Date: | Feb 2, 2026 | TE: | RLD: | No | |||||
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