Details for New Drug Application (NDA): 080937
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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.
Suppliers and Packaging for NDA: 080937
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISONIAZID | isoniazid | TABLET;ORAL | 080937 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0071 | 0555-0071-01 | 30 TABLET in 1 BOTTLE, UNIT-DOSE (0555-0071-01) |
ISONIAZID | isoniazid | TABLET;ORAL | 080937 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0071 | 0555-0071-02 | 100 TABLET in 1 BOTTLE (0555-0071-02) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | No |
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