Details for New Drug Application (NDA): 065287
✉ Email this page to a colleague
NDA 065287 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Endo Operations, Gland Pharma Ltd, Heritage, Kindos, Lupin Ltd, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent, and is included in eighty-two NDAs. It is available from sixty-six suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.
The generic ingredient in DOXYCYCLINE HYCLATE 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 HYCLATE 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 065287
| Tradename: | DOXYCYCLINE HYCLATE |
| Applicant: | Larken Labs |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065287
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 065287 | ANDA | Larken Laboratories, Inc. | 68047-714 | 68047-714-01 | 100 TABLET in 1 BOTTLE (68047-714-01) |
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 065287 | ANDA | Larken Laboratories, Inc. | 68047-714 | 68047-714-60 | 60 TABLET in 1 BOTTLE (68047-714-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Feb 28, 2006 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
