Shandong Xinhua Pharmaceutical
FDA Approved Drugs

Shandong Xinhua Pharmaceutical

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX OTC
  • Total Records 11
  • Latest Approval Date Oct 24, 2024
  • Data Source FDA
  • First Approval Date Nov 23, 2016
All
11
View
OTC
2
View
RX
9
View
Company Overview

Company

Shandong Xinhua Pharmaceutical

Country

China

Website

Visit Website

Email

pengxinwen@xhzy.com

Social Profiles

Company Snapshot

Shandong Xinhua Pharmaceutical

No. 1 Lutai Avenue, Zibo High-tech Zone, Shandong Province

China

xhzy.com/html/english/default.aspx pengxinwen@xhzy.com View on Map
FDA Approved Drug Records ( 11 records )
2024
25 Jan
RX Application: 211886

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-01-25

211886 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

211886

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-01-25

Regulatory Status

RX

2024
25 Jan
RX Application: 211886

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-01-25

211886 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

211886

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-01-25

Regulatory Status

RX

2024
25 Jan
RX Application: 211886

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2024-01-25

211886 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

211886

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2024-01-25

Regulatory Status

RX

2024
25 Jan
RX Application: 211886

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2024-01-25

211886 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

211886

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2024-01-25

Regulatory Status

RX

2016
23 Nov
RX Application: 202413

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2016-11-23

202413 / 1

Active Ingredient

IBUPROFEN

Application Number

202413

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2016-11-23

Regulatory Status

RX

2016
23 Nov
RX Application: 202413

Drug Name

IBUPROFEN

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2016-11-23

202413 / 2

Active Ingredient

IBUPROFEN

Application Number

202413

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2016-11-23

Regulatory Status

RX

2016
23 Nov
RX Application: 202413

Drug Name

IBUPROFEN

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

2016-11-23

202413 / 3

Active Ingredient

IBUPROFEN

Application Number

202413

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

2016-11-23

Regulatory Status

RX

2024
05 Jul
RX Application: 202413

Drug Name

IBUPROFEN

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2024-07-05

202413 / 4

Active Ingredient

IBUPROFEN

Application Number

202413

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2024-07-05

Regulatory Status

RX

2017
05 May
OTC Application: 207095

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2017-05-05

207095 / 1

Active Ingredient

IBUPROFEN

Application Number

207095

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2017-05-05

Regulatory Status

OTC

2018
21 Aug
OTC Application: 207095

Drug Name

IBUPROFEN

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2018-08-21

207095 / 2

Active Ingredient

IBUPROFEN

Application Number

207095

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2018-08-21

Regulatory Status

OTC

2024
24 Oct
RX Application: 215998

Drug Name

SEVELAMER CARBONATE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2024-10-24

215998 / 1

Active Ingredient

SEVELAMER CARBONATE

Application Number

215998

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2024-10-24

Regulatory Status

RX

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Drug Status Breakdown
11 total
  • RX
  • OTC
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ATORVASTATIN CALCIUM

Application Number

211886

Product Number

1

Active Ingredient

ATORVASTATIN CALCIUM

Dosage Form

-

Strength

EQ 10MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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