NDA and ANDA Preparation

Levamlodipine Maleate Tablets (Conjupri®)

FEATURE

Conjupri® is the first NDA that has been fully approved by the USFDA in China.

DOSAGE FORM

Tablet, oral

INDICATION

1. Hypertension. To use this drug solely or combined with other antihypertensive drugs.
2. Chronic stable angina and variant angina. To use this drug solely or combined with other anti-angina drugs.

Metformin Hydrochloride Extended-Release Tablets

DOSAGE FORM

Tablet, extended release, oral

INDICATION

Metformin hydrochloride extended-release tablets indicate as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Metformin Hydrochloride Tablets

DOSAGE FORM

Tablet, oral

INDICATION

Metformin hydrochloride tablets indicate as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Azithromycin Tablets

FEATURE

Azithromycin Tablets are integrated products from API to finished dosage form by CSPC.

DOSAGE FORM

Tablet, oral

INDICATION

Anti-infection

Tramadol Hydrochloride Tablets

FEATURE

Tramadol Hydrochloride Tablets are integrated products from API to finished dosage form by CSPC.

DOSAGE FORM

Tablet, oral

INDICATION

Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults.

Carbamazepine Extended-Release Tablets

DOSAGE FORM

Tablet, extended release, oral

INDICATION

Carbamazepine Extended-Release Tables are used to control seizures caused by certain types of epilepsy.

Paliperidone Extended-Release Tablets

DOSAGE FORM

Tablet, extended release, oral

INDICATION

Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy.

Gabapentin Tablets

DOSAGE FORM

Tablet, oral

INDICATION

Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

Gabapentin Capsules

DOSAGE FORM

Capsule, oral

INDICATION

Gabapentin Capsules are indicated for management of postherpetic neuralgia in adults adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

Celecoxib Capsules

DOSAGE FORM

Capsule, oral

INDICATION

Celecoxib Capsules are used to treat various forms of arthritis, short-term pain, and menstrual cramps.

Paroxetine Extended-Release Tablets

DOSAGE FORM

Tablet, extended release, oral

INDICATION

Paroxetine extended-release tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of:

• Major Depressive Disorder (MDD)

• Panic Disorder (PD)

• Social Anxiety Disorder (SAD)

• Premenstrual Dysphoric Disorder (PMDD)

Esomeprazole Delayed Release Capsules

DOSAGE FORM

Capsule, delayed release, oral

INDICATION

Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor indicated for the following:

• Treatment of gastroesophageal reflux disease (GERD).

• Risk reduction of NSAID-associated gastric ulcer.

• H. pylori eradication to reduce the risk of duodenal ulcer recurrence.

• Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Benzonatate Capsules

DOSAGE FORM

Capsule, oral

INDICATION

Benzonatate Capsules are indicated for the symptomatic relief of cough.

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Name:Tina Tian

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