Details for New Drug Application (NDA): 019537
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NDA 019537 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Sandoz, Bayer Pharms, Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Sentiss, Sun Pharm, Ani Pharms, Dr Reddys Labs Ltd, Endo Operations, Fosun Pharma, Rising, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in sixty NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the CIPRO profile page.
The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Summary for 019537
| Tradename: | CIPRO |
| Applicant: | Bayer Hlthcare |
| Ingredient: | ciprofloxacin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 019537
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 019537
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIPRO | ciprofloxacin hydrochloride | TABLET;ORAL | 019537 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-754 | 50419-754-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01) |
| CIPRO | ciprofloxacin hydrochloride | TABLET;ORAL | 019537 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-758 | 50419-758-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-758-01) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Oct 22, 1987 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Oct 22, 1987 | TE: | AB | RLD: | Yes | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 22, 1987 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 019537
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | CIPRO | ciprofloxacin hydrochloride | TABLET;ORAL | 019537-003 | Oct 22, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | CIPRO | ciprofloxacin hydrochloride | TABLET;ORAL | 019537-002 | Oct 22, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | CIPRO | ciprofloxacin hydrochloride | TABLET;ORAL | 019537-003 | Oct 22, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | CIPRO | ciprofloxacin hydrochloride | TABLET;ORAL | 019537-004 | Oct 22, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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