Details for New Drug Application (NDA): 212435
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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-one 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 |
Formulation / Manufacturing: | see details |
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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