Details for New Drug Application (NDA): 040090
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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 040090
Tradename: | ISONIAZID |
Applicant: | Omnivium Pharms |
Ingredient: | isoniazid |
Patents: | 0 |
Suppliers and Packaging for NDA: 040090
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISONIAZID | isoniazid | TABLET;ORAL | 040090 | ANDA | OMNIVIUM PHARMACEUTICALS LLC. | 81665-107 | 81665-107-10 | 100 TABLET in 1 BOTTLE, PLASTIC (81665-107-10) |
ISONIAZID | isoniazid | TABLET;ORAL | 040090 | ANDA | OMNIVIUM PHARMACEUTICALS LLC. | 81665-108 | 81665-108-10 | 100 TABLET in 1 BOTTLE, PLASTIC (81665-108-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jun 26, 1997 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jun 26, 1997 | TE: | AA | RLD: | No |
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