Details for New Drug Application (NDA): 065285
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NDA 065285 describes DOXYCYCLINE, which is a drug marketed by Alembic, Apotex, Changzhou Pharm, 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, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Aspiro, Gland, Kindos, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Avet Lifesciences, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Pharmobedient, Praxgen, and Torrent, and is included in one hundred and twenty-three NDAs. It is available from thirty-five 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-six 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-six suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 065285
| Tradename: | DOXYCYCLINE |
| Applicant: | Lannett Co Inc |
| Ingredient: | doxycycline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065285
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | doxycycline | TABLET;ORAL | 065285 | ANDA | Lannett Company, Inc. | 0527-1335 | 0527-1335-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1335-01) |
| DOXYCYCLINE | doxycycline | TABLET;ORAL | 065285 | ANDA | Lannett Company, Inc. | 0527-1338 | 0527-1338-25 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1338-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Dec 8, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Dec 8, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Jul 30, 2008 | TE: | AB | RLD: | No | ||||
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