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 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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