Details for New Drug Application (NDA): 065055
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NDA 065055 describes DOXYCYCLINE, which is a drug marketed by Alembic, Apotex, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Heritage, Lannett Co Inc, Somerset Theraps Llc, Sun Pharm Industries, Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Endo Operations, Gland Pharma Ltd, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent, and is included in one hundred and twelve NDAs. It is available from forty-one 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 065055
| Tradename: | DOXYCYCLINE |
| Applicant: | Strides Pharma |
| Ingredient: | doxycycline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065055
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | doxycycline | CAPSULE;ORAL | 065055 | ANDA | Par Pharmaceutical, Inc. | 49884-726 | 49884-726-01 | 100 CAPSULE in 1 BOTTLE (49884-726-01) |
| DOXYCYCLINE | doxycycline | CAPSULE;ORAL | 065055 | ANDA | Par Pharmaceutical, Inc. | 49884-727 | 49884-727-03 | 50 CAPSULE in 1 BOTTLE (49884-727-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Dec 1, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Dec 1, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jul 15, 2005 | TE: | AB | RLD: | No | ||||
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