Details for New Drug Application (NDA): 080936
NDA 080936 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 080936
| Tradename: | ISONIAZID |
| Applicant: | Genus Lifesciences |
| Ingredient: | isoniazid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 080936
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISONIAZID | isoniazid | TABLET;ORAL | 080936 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0066 | 0555-0066-02 | 100 TABLET in 1 BOTTLE (0555-0066-02) |
| ISONIAZID | isoniazid | TABLET;ORAL | 080936 | ANDA | A-S Medication Solutions | 50090-0410 | 50090-0410-0 | 100 TABLET in 1 BOTTLE (50090-0410-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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