Details for New Drug Application (NDA): 080132
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NDA 080132 describes ISONIAZID, which is a drug marketed by Sandoz, Chartwell Rx, Cmp Pharma Inc, Barr, Duramed Pharms Barr, Epic Pharma Llc, Halsey, Hikma Intl Pharms, 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-four NDAs. It is available from sixteen suppliers. Additional details are available on the ISONIAZID profile page.
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.
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 080132
| Tradename: | ISONIAZID |
| Applicant: | Purepac Pharm |
| Ingredient: | isoniazid |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 080132
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 14, 1982 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 14, 1982 | TE: | RLD: | No | |||||
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