Details for New Drug Application (NDA): 205115
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NDA 205115 describes DOXYCYCLINE, which is a drug marketed by Aiping Pharm Inc, Alembic, Apotex, Cosette Pharms Nc, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Macleods Pharms, Prinston Inc, Rising, Sandoz Inc, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Lupin Ltd, Hikma, Mylan Labs Ltd, Chartwell Rx, Heritage, Lannett Co Inc, Sun Pharm Industries, Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Aspiro, Avet Lifesciences, Gland, Hainan Poly, Kindos, Ph Health, Pharmobedient, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Arthur Grp, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, and Torrent, and is included in one hundred and twenty-four 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 two drug master file entries for this compound. Seventy-seven 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 two drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 205115
| Tradename: | DOXYCYCLINE |
| Applicant: | Zydus Pharms |
| Ingredient: | doxycycline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205115
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | doxycycline | CAPSULE;ORAL | 205115 | ANDA | Safecor Health, LLC | 48433-158 | 48433-158-03 | 30 BLISTER PACK in 1 CARTON (48433-158-03) / 1 CAPSULE in 1 BLISTER PACK (48433-158-01) |
| DOXYCYCLINE | doxycycline | CAPSULE;ORAL | 205115 | ANDA | Safecor Health, LLC | 48433-159 | 48433-159-03 | 30 BLISTER PACK in 1 CARTON (48433-159-03) / 1 CAPSULE in 1 BLISTER PACK (48433-159-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Feb 18, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Feb 18, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Feb 18, 2016 | TE: | AB | RLD: | No | ||||
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