Details for New Drug Application (NDA): 062538
NDA 062538 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Bionpharma, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma, Interpharm, Macleods Pharms, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Aspiro, Avet Lifesciences, Dr Reddys, Gland, Hainan Poly, Heritage, Kindos, Lupin, Ph Health, Pharmobedient, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal Pharms Co, Apotex, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Quagen, Strides Pharma Intl, and Torrent, and is included in ninety NDAs. It is available from seventy suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.
The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There is one drug master file entry 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 HYCLATE is doxycycline hyclate. There is one drug master file entry for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 062538
| Tradename: | DOXYCYCLINE HYCLATE |
| Applicant: | Strides Pharma Intl |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062538
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 062538 | ANDA | Strides Pharma Science Limited | 64380-225 | 64380-225-01 | 60 TABLET in 1 BOTTLE (64380-225-01) |
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 062538 | ANDA | Strides Pharma Science Limited | 64380-226 | 64380-226-02 | 500 TABLET in 1 BOTTLE (64380-226-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Apr 7, 1986 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Nov 24, 2025 | TE: | AB | RLD: | No | ||||
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