Details for New Drug Application (NDA): 081118
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NDA 081118 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 081118
| Tradename: | ISONIAZID |
| Applicant: | Chartwell Rx |
| Ingredient: | isoniazid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 081118
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISONIAZID | isoniazid | SYRUP;ORAL | 081118 | ANDA | Chartwell RX, LLC | 62135-550 | 62135-550-47 | 473 mL in 1 BOTTLE (62135-550-47) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 50MG/5ML | ||||
| Approval Date: | Jul 21, 1997 | TE: | RLD: | No | |||||
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