Details for New Drug Application (NDA): 061837
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NDA 061837 describes TETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Abbott, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Chartwell Tetra, Elkins Sinn, Ferrante, Heather, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mast Mm, Novitium Pharma, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Valeant Pharm Intl, Warner Chilcott, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, and Proter, and is included in twenty-nine NDAs. It is available from seven suppliers. Additional details are available on the TETRACYCLINE HYDROCHLORIDE profile page.
The generic ingredient in TETRACYCLINE HYDROCHLORIDE is tetracycline hydrochloride. There are ninety-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.
The generic ingredient in TETRACYCLINE HYDROCHLORIDE is tetracycline hydrochloride. There are ninety-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.
Summary for 061837
| Tradename: | TETRACYCLINE HYDROCHLORIDE |
| Applicant: | Watson Labs |
| Ingredient: | tetracycline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 061837
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TETRACYCLINE HYDROCHLORIDE | tetracycline hydrochloride | CAPSULE;ORAL | 061837 | ANDA | Actavis Pharma, Inc. | 0591-2474 | 0591-2474-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2474-01) |
| TETRACYCLINE HYDROCHLORIDE | tetracycline hydrochloride | CAPSULE;ORAL | 061837 | ANDA | Actavis Pharma, Inc. | 0591-2475 | 0591-2475-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2475-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
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