Details for New Drug Application (NDA): 019193
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NDA 019193 describes PROVOCHOLINE, which is a drug marketed by Methapharm and is included in one NDA. It is available from one supplier. Additional details are available on the PROVOCHOLINE profile page.
The generic ingredient in PROVOCHOLINE is methacholine chloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methacholine chloride profile page.
The generic ingredient in PROVOCHOLINE is methacholine chloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methacholine chloride profile page.
Summary for 019193
| Tradename: | PROVOCHOLINE |
| Applicant: | Methapharm |
| Ingredient: | methacholine chloride |
| Patents: | 0 |
Pharmacology for NDA: 019193
| Mechanism of Action | Cholinergic Agonists |
Medical Subject Heading (MeSH) Categories for 019193
Suppliers and Packaging for NDA: 019193
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROVOCHOLINE | methacholine chloride | FOR SOLUTION;INHALATION | 019193 | NDA | Methapharm Inc. | 64281-100 | 64281-100-06 | 6 VIAL, GLASS in 1 BOX (64281-100-06) / 100 mg in 1 VIAL, GLASS (64281-100-00) |
| PROVOCHOLINE | methacholine chloride | FOR SOLUTION;INHALATION | 019193 | NDA | Methapharm Inc. | 64281-110 | 64281-110-06 | 6 PACKAGE in 1 PACKAGE (64281-110-06) / 6 CARTON in 1 PACKAGE (64281-110-05) / 1 KIT in 1 CARTON * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-113-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-115-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-114-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-116-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-112-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-111-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;INHALATION | Strength | 100MG/VIAL | ||||
| Approval Date: | Oct 31, 1986 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;INHALATION | Strength | 1600MG/VIAL | ||||
| Approval Date: | Aug 29, 2016 | TE: | RLD: | Yes | |||||
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