Details for New Drug Application (NDA): 019537
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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Dosage: | TABLET;ORAL | Strength | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | 019537-002 | 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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