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Details for New Drug Application (NDA): 091406
» See Plans and Pricing
NDA 091406 describes DOXYCYCLINE, which is a drug marketed by Alembic Pharms Ltd, Cosette, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Life Sci, Mylan Labs Ltd, West-ward Pharms Int, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Actavis Elizabeth, Prinston Inc, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, Oaklock Llc, and Vintage Pharms, and is included in ninety-two NDAs. It is available from thirty-seven 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 |
| Formulation / Manufacturing: | see details |
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 | General Injectables & Vaccines, Inc. | 52584-437 | 52584-437-00 | 1 PACKAGE in 1 BAG (52584-437-00) > 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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