Details for New Drug Application (NDA): 089776
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NDA 089776 describes LANIAZID, which is a drug marketed by Lannett and Chartwell Molecular and is included in three NDAs. It is available from two suppliers. Additional details are available on the LANIAZID profile page.
The generic ingredient in LANIAZID 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 LANIAZID 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 089776
| Tradename: | LANIAZID |
| Applicant: | Chartwell Molecular |
| Ingredient: | isoniazid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 089776
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LANIAZID | isoniazid | TABLET;ORAL | 089776 | ANDA | Chartwell RX, LLC | 62135-709 | 62135-709-90 | 90 TABLET in 1 BOTTLE (62135-709-90) |
| LANIAZID | isoniazid | TABLET;ORAL | 089776 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-108 | 71610-108-30 | 30 TABLET in 1 BOTTLE (71610-108-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Jun 13, 1988 | TE: | RLD: | No | |||||
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