Details for New Drug Application (NDA): 200890
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NDA 200890 describes ISOPTO CARPINE, which is a drug marketed by Sandoz and is included in one NDA. It is available from one supplier. Additional details are available on the ISOPTO CARPINE profile page.
The generic ingredient in ISOPTO CARPINE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
The generic ingredient in ISOPTO CARPINE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 200890
| Tradename: | ISOPTO CARPINE |
| Applicant: | Sandoz |
| Ingredient: | pilocarpine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200890
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOPTO CARPINE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 200890 | NDA AUTHORIZED GENERIC | Sandoz Inc | 61314-203 | 61314-203-15 | 1 BOTTLE in 1 CARTON (61314-203-15) / 15 mL in 1 BOTTLE |
| ISOPTO CARPINE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 200890 | NDA AUTHORIZED GENERIC | Sandoz Inc | 61314-204 | 61314-204-15 | 1 BOTTLE in 1 CARTON (61314-204-15) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Jun 22, 2010 | TE: | AT | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 2% | ||||
| Approval Date: | Jun 22, 2010 | TE: | AT | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 4% | ||||
| Approval Date: | Jun 22, 2010 | TE: | AT | RLD: | Yes | ||||
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