Details for New Drug Application (NDA): 065454
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NDA 065454 describes DOXYCYCLINE, which is a drug marketed by Aiping Pharm Inc, Alembic, Apotex, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Rising, Sandoz Inc, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Chartwell Rx, Heritage, Lannett Co Inc, Sun Pharm Industries, Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Aspiro, Avet Lifesciences, Gland, Kindos, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Pharmobedient, Praxgen, and Torrent, and is included in one hundred and twenty-four NDAs. It is available from thirty-six suppliers. Additional details are available on the DOXYCYCLINE profile page.
The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 065454
| Tradename: | DOXYCYCLINE |
| Applicant: | Chartwell |
| Ingredient: | doxycycline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065454
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | doxycycline | FOR SUSPENSION;ORAL | 065454 | ANDA | Chartwell RX LLC | 62135-417 | 62135-417-46 | 60 mL in 1 BOTTLE, GLASS (62135-417-46) |
| DOXYCYCLINE | doxycycline | FOR SUSPENSION;ORAL | 065454 | ANDA | Chartwell RX LLC | 62135-877 | 62135-877-46 | 60 mL in 1 BOTTLE, GLASS (62135-877-46) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 25MG BASE/5ML | ||||
| Approval Date: | Jul 16, 2008 | TE: | AB | RLD: | No | ||||
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