Details for New Drug Application (NDA): 214193
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The generic ingredient in PILOCARPINE HYDROCHLORIDE 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 214193
Tradename: | PILOCARPINE HYDROCHLORIDE |
Applicant: | Amneal |
Ingredient: | pilocarpine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214193
Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 214193
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 214193 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1745 | 69238-1745-8 | 1 BOTTLE in 1 CARTON (69238-1745-8) / 15 mL in 1 BOTTLE |
PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 214193 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1746 | 69238-1746-8 | 1 BOTTLE in 1 CARTON (69238-1746-8) / 15 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 1% | ||||
Approval Date: | Sep 21, 2020 | TE: | AT | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 2% | ||||
Approval Date: | Sep 21, 2020 | TE: | AT | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 4% | ||||
Approval Date: | Sep 21, 2020 | TE: | AT | RLD: | No |
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