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FDA Approval

Pilocarpine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Somerset Therapeutics, LLC

DUNS: 079947873

Effective Date

April 26, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pilocarpine(40 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Somerset Therapeutics, LLC

DUNS Number

079947873

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Somerset Therapeutics Limited

Labeler

Somerset Therapeutics, LLC

Registrant

Somerset Therapeutics, LLC

DUNS Number

677236695

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pilocarpine Hydrochloride

Product Details

NDC Product Code

70069-201

Application Number

ANDA210384

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

April 26, 2023

Ingredients

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

HYPROMELLOSE 2910 (4000 MPA.S)Inactive

Code: RN3152OP35Class: IACT

PilocarpineActive

Code: 0WW6D218XJClass: ACTIBQuantity: 40 mg in 1 mL

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Pilocarpine Hydrochloride

Product Details

NDC Product Code

70069-181

Application Number

ANDA210384

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

April 26, 2023

Ingredients

PilocarpineActive

Code: 0WW6D218XJClass: ACTIBQuantity: 10 mg in 1 mL

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

HYPROMELLOSE 2910 (4000 MPA.S)Inactive

Code: RN3152OP35Class: IACT

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Pilocarpine Hydrochloride

Product Details

NDC Product Code

70069-191

Application Number

ANDA210384

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

April 26, 2023

Ingredients

PilocarpineActive

Code: 0WW6D218XJClass: ACTIBQuantity: 20 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

HYPROMELLOSE 2910 (4000 MPA.S)Inactive

Code: RN3152OP35Class: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

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Pilocarpine Hydrochloride - FDA Approval | MedPath