Details for New Drug Application (NDA): 088235
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The generic ingredient in ISONIAZID is isoniazid. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.
Summary for 088235
Tradename: | ISONIAZID |
Applicant: | Cmp Pharma Inc |
Ingredient: | isoniazid |
Patents: | 0 |
Suppliers and Packaging for NDA: 088235
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISONIAZID | isoniazid | SYRUP;ORAL | 088235 | ANDA | CMP Pharma, Inc. | 46287-009 | 46287-009-01 | 473 mL in 1 BOTTLE (46287-009-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 50MG/5ML | ||||
Approval Date: | Nov 10, 1983 | TE: | RLD: | Yes |
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