Details for New Drug Application (NDA): 210384
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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 210384
Tradename: | PILOCARPINE HYDROCHLORIDE |
Applicant: | Somerset Theraps Llc |
Ingredient: | pilocarpine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210384
Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 210384
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 210384 | ANDA | Somerset Therapeutics, LLC | 70069-181 | 70069-181-01 | 1 BOTTLE in 1 CARTON (70069-181-01) / 15 mL in 1 BOTTLE |
PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 210384 | ANDA | Somerset Therapeutics, LLC | 70069-191 | 70069-191-01 | 1 BOTTLE in 1 CARTON (70069-191-01) / 15 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 1% | ||||
Approval Date: | Nov 25, 2019 | TE: | AT | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 2% | ||||
Approval Date: | Nov 25, 2019 | TE: | AT | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 4% | ||||
Approval Date: | Nov 25, 2019 | TE: | AT | RLD: | No |
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