Details for New Drug Application (NDA): 008678
NDA 008678 describes ISONIAZID, which is a drug marketed by Sandoz, Chartwell Rx, Cmp Pharma Inc, Duramed Pharms Barr, Epic Pharma Llc, Genus Lifesciences, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Omnivium Pharms, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, and Whiteworth Town Plsn, and is included in thirty-three NDAs. It is available from fourteen suppliers. Additional details are available on the ISONIAZID profile page.
The generic ingredient in ISONIAZID is isoniazid. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.
The generic ingredient in ISONIAZID is isoniazid. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.
Summary for 008678
| Tradename: | ISONIAZID |
| Applicant: | Epic Pharma Llc |
| Ingredient: | isoniazid |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 008678
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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