Details for New Drug Application (NDA): 065447
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NDA 065447 describes DEMECLOCYCLINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharm, Barr, Epic Pharma Llc, and Impax Labs, and is included in five NDAs. It is available from five suppliers. Additional details are available on the DEMECLOCYCLINE HYDROCHLORIDE profile page.
The generic ingredient in DEMECLOCYCLINE HYDROCHLORIDE is demeclocycline hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.
The generic ingredient in DEMECLOCYCLINE HYDROCHLORIDE is demeclocycline hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.
Summary for 065447
| Tradename: | DEMECLOCYCLINE HYDROCHLORIDE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | demeclocycline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065447
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEMECLOCYCLINE HYDROCHLORIDE | demeclocycline hydrochloride | TABLET;ORAL | 065447 | ANDA | PuraCap Laboratories LLC | 24658-710 | 24658-710-01 | 100 TABLET, FILM COATED in 1 BOTTLE (24658-710-01) |
| DEMECLOCYCLINE HYDROCHLORIDE | demeclocycline hydrochloride | TABLET;ORAL | 065447 | ANDA | PuraCap Laboratories LLC | 24658-711 | 24658-711-48 | 48 TABLET, FILM COATED in 1 BOTTLE (24658-711-48) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Aug 18, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 18, 2015 | TE: | AB | RLD: | No | ||||
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