Details for New Drug Application (NDA): 212435
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NDA 212435 describes METRONIDAZOLE IN PLASTIC CONTAINER, which is a drug marketed by Amneal, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, and Rising, and is included in six NDAs. It is available from six suppliers. Additional details are available on the METRONIDAZOLE IN PLASTIC CONTAINER profile page.
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.
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 212435
| Tradename: | METRONIDAZOLE IN PLASTIC CONTAINER |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | metronidazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212435
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METRONIDAZOLE IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 212435 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-993 | 47335-993-01 | 1 BAG in 1 POUCH (47335-993-01) / 100 mL in 1 BAG |
| METRONIDAZOLE IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 212435 | ANDA | Gland Pharma Limited | 68083-373 | 68083-373-04 | 4 POUCH in 1 CARTON (68083-373-04) / 1 BAG in 1 POUCH (68083-373-01) / 100 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/100ML | ||||
| Approval Date: | Aug 3, 2020 | TE: | AP | RLD: | No | ||||
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