Details for New Drug Application (NDA): 217665
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The generic ingredient in METRONIDAZOLE IN PLASTIC CONTAINER is metronidazole. There are eighteen drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 217665
Tradename: | METRONIDAZOLE IN PLASTIC CONTAINER |
Applicant: | Amneal |
Ingredient: | metronidazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 217665
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 217665 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-2465 | 80830-2465-9 | 24 POUCH in 1 CARTON (80830-2465-9) / 1 BAG in 1 POUCH (80830-2465-1) / 100 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/100ML | ||||
Approval Date: | May 24, 2023 | TE: | AP | RLD: | No |
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