Details for New Drug Application (NDA): 204234
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NDA 204234 describes DOXYCYCLINE, which is a drug marketed by Alembic, Cosette, Dr Reddys Labs Sa, Impax Labs Inc, Lupin Ltd, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Appco, Heritage Pharms, Lannett Co Inc, 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, Gland Pharma Ltd, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Lupin, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Pharmobedient, and Praxgen, and is included in one hundred and three NDAs. It is available from thirty-nine 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-two 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-two suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 204234
| Tradename: | DOXYCYCLINE |
| Applicant: | Lupin Ltd |
| Ingredient: | doxycycline |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204234
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | doxycycline | CAPSULE;ORAL | 204234 | ANDA | Northwind Pharmaceuticals, LLC | 51655-711 | 51655-711-20 | 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-711-20) |
| DOXYCYCLINE | doxycycline | CAPSULE;ORAL | 204234 | ANDA | Proficient Rx LP | 63187-672 | 63187-672-02 | 2 CAPSULE in 1 BOTTLE (63187-672-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Mar 5, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Mar 5, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Mar 5, 2014 | TE: | AB | RLD: | No | ||||
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