Details for New Drug Application (NDA): 091406
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NDA 091406 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, Kindos, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Avet Lifesciences, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent, and is included in one hundred and thirteen NDAs. It is available from forty 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 091406
| Tradename: | DOXYCYCLINE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091406
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | doxycycline hyclate | INJECTABLE;INJECTION | 091406 | ANDA | Henry Schein, Inc | 0404-9855 | 0404-9855-99 | 1 PACKAGE in 1 BAG (0404-9855-99) / 10 mL in 1 PACKAGE |
| DOXYCYCLINE | doxycycline hyclate | INJECTABLE;INJECTION | 091406 | ANDA | Mylan Institutional LLC | 67457-437 | 67457-437-10 | 10 VIAL in 1 CARTON (67457-437-10) / 10 mL in 1 VIAL (67457-437-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Aug 21, 2012 | TE: | AP | RLD: | No | ||||
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