Details for New Drug Application (NDA): 212635
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NDA 212635 describes TETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Abbott, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Chartwell Tetra, Elkins Sinn, Esjay Pharma, Ferrante, Heather, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mast Mm, 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 212635
| Tradename: | TETRACYCLINE HYDROCHLORIDE |
| Applicant: | Esjay Pharma |
| Ingredient: | tetracycline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212635
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TETRACYCLINE HYDROCHLORIDE | tetracycline hydrochloride | CAPSULE;ORAL | 212635 | ANDA | Strides Pharma Science Limited | 64380-890 | 64380-890-06 | 100 CAPSULE in 1 BOTTLE (64380-890-06) |
| TETRACYCLINE HYDROCHLORIDE | tetracycline hydrochloride | CAPSULE;ORAL | 212635 | ANDA | Strides Pharma Science Limited | 64380-891 | 64380-891-06 | 100 CAPSULE in 1 BOTTLE (64380-891-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Mar 3, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Mar 3, 2020 | TE: | AB | RLD: | No | ||||
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