Details for New Drug Application (NDA): 080937
NDA 080937 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 080937
| Tradename: | ISONIAZID |
| Applicant: | Genus Lifesciences |
| Ingredient: | isoniazid |
| Patents: | 0 |
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: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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