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FDA Orange Book

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ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 4 EU WC, 21 NDC API, 15 Listed Suppliers

39 API Suppliers
12 USDMF
4 CEP/COS
2 JDMF
4 EU WC
21 NDC API
15 Listed Suppliers

DEVELOPMENTS

123 Drugs in Development

123 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

402 FDF Dossiers, 102 FDA Orange Book, 228 Europe, 17 Canada, 20 Australia, 15 South Africa, 20 Listed Dossiers

402 FDF Dossiers
102 FDA Orange Book
228 Europe
17 Canada
20 Australia
15 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - 0.15MG/DELIVERY, INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - 0.3MG/DELIVERY, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.15MG/DELIVERY, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.1MG/DELIVERY, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY, SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 30MG BASE/30ML (EQ 1MG BASE/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 10MG/10ML (1MG/ML), SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS - 1MG/ML (1MG/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 30MG/30ML (1MG/ML), SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.15MG/0.3ML (0.15MG/0.3ML), SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.3MG/0.3ML (0.3MG/0.3ML), INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.15MG/DELIVERY, INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY, INJECTABLE;INJECTION - 0.005MG/ML;0.5%, INJECTABLE;INJECTION - 0.005MG/ML;1%, INJECTABLE;INJECTION - 0.005MG/ML;1.5%, INJECTABLE;INJECTION - 0.005MG/ML;2%, INJECTABLE;INJECTION - 0.01MG/ML;1%, INJECTABLE;INJECTION - 0.01MG/ML;2%, INJECTABLE;INJECTION - 0.02MG/ML;2%, INJECTABLE;INJECTION - 0.5%, INJECTABLE;INJECTION - 1%, INJECTABLE;INJECTION - 1.5%, INJECTABLE;INJECTION - 2%

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - 0.15MG/DELIVERY
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - 0.3MG/DELIVERY
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.15MG/DELIVERY
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.1MG/DELIVERY
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 10MG/10ML (1MG/ML)
SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS - 1MG/ML (1MG/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 30MG/30ML (1MG/ML)
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.15MG/0.3ML (0.15MG/0.3ML)
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.3MG/0.3ML (0.3MG/0.3ML)
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.15MG/DELIVERY
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY
INJECTABLE;INJECTION - 0.005MG/ML;0.5%
INJECTABLE;INJECTION - 0.005MG/ML;1%
INJECTABLE;INJECTION - 0.005MG/ML;1.5%
INJECTABLE;INJECTION - 0.005MG/ML;2%
INJECTABLE;INJECTION - 0.01MG/ML;1%
INJECTABLE;INJECTION - 0.01MG/ML;2%
INJECTABLE;INJECTION - 0.02MG/ML;2%
INJECTABLE;INJECTION - 0.5%
INJECTABLE;INJECTION - 1%
INJECTABLE;INJECTION - 1.5%
INJECTABLE;INJECTION - 2%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 9 Rochem International Inc, 19 SPI Pharma, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 6 Kirsch Pharma, 1 Cerata Pharmaceuticals LLP, 5 Dr. Paul Lohmann GmbH & Co. KGaA, 11 Actylis, 2 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 9 BASF, 8 Beneo, 1 Bioplus Life Sciences, 1 CD Formulation, 2 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 2 Ideal Cures, 3 Ingredion Pharma Solutions, 3 Kerry, 1 Keval Exports, 13 Microlex e.U, 2 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Pharmachem, 33 Roquette, 2 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 3 Silverline Chemicals, 1 Symrise, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 40 Taste Masking, 32 Direct Compression, 26 Thickeners and Stabilizers, 24 Disintegrants & Superdisintegrants, 24 Chewable & Orodispersible Aids, 19 Parenteral, 18 Coating Systems & Additives, 17 Film Formers & Plasticizers, 16 Granulation, 14 Lubricants & Glidants, 13 Co-Processed Excipients, 8 Solubilizers, 8 Controlled & Modified Release, 6 API Stability Enhancers, 6 Topical, 4 Emulsifying Agents, 1 Soft Gelatin, 1 Rheology Modifiers

68 Fillers, Diluents & Binders
40 Taste Masking
32 Direct Compression
26 Thickeners and Stabilizers
24 Disintegrants & Superdisintegrants
24 Chewable & Orodispersible Aids
19 Parenteral
18 Coating Systems & Additives
17 Film Formers & Plasticizers
16 Granulation
14 Lubricants & Glidants
13 Co-Processed Excipients
8 Solubilizers
8 Controlled & Modified Release
6 API Stability Enhancers
6 Topical
4 Emulsifying Agents
1 Soft Gelatin
1 Rheology Modifiers

DIGITAL CONTENT

5 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 531 News #PharmaBuzz

5 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
531 News #PharmaBuzz

GLOBAL SALES INFORMATION

11 US Medicaid Prescriptions, 76 Regulatory FDF Prices, 21 Annual Reports

11 US Medicaid Prescriptions
76 Regulatory FDF Prices
21 Annual Reports

MARKET PLACE

26 APIs, 26 FDF Dossiers

26 APIs
26 FDF Dossiers

PATENTS & EXCLUSIVITIES

71 US Patents

71 US Patents

REF. STANDARDS & IMPURITIES

3 USP, 6 Others

3 USP
6 Others

Xls

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FILTER :

filter Applicant Reset all filters

105 All

01 1ABBOTT

02 1ADAMIS PHARMS CORP

03 2AM REGENT

04 2AMNEAL

05 1ARMSTRONG PHARMS

06 2ARS PHARMS OPERATION

07 4ASTRAZENECA

08 1B BRAUN MEDICAL

09 2BAXTER HLTHCARE CORP

10 4BEL MAR

11 1BELMORA LLC

12 5BPI LABS

13 1CHEMI SPA

14 2DELL LABS

15 2DENTSPLY PHARM

16 2DR REDDYS

17 2EASTMAN KODAK

18 1EMPI

19 2FOREST LABS

20 9FRESENIUS KABI USA

21 5GLAND

22 10HOSPIRA

23 1HOSPIRA INC

24 4IMPAX

25 1INTL MEDICATION

26 2INTL MEDICATION SYS

27 1IOMED

28 3KALEO INC

29 1ORTHO MCNEIL PHARM

30 1PADAGIS ISRAEL

31 7PH HEALTH

32 3PHARMATON

33 2SEPTODONT

34 3SLATE RUN PHARMA

35 1STERLING

36 2TEVA PHARMS USA

37 4VIATRIS

38 1VYTERIS

39 3WATSON LABS

40 2WEST-WARD PHARMS INT

41 1WYETH CONS

filter Dosage Reset all filters

105 All

01 3AEROSOL, METERED;INHALATION

02 2CAPSULE;ORAL

03 47INJECTABLE;INJECTION

04 2INJECTABLE;INTRAMUSCULAR

05 8INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

06 2INJECTION;SOLUTION,CONCENTRATE

07 1OINTMENT;TOPICAL

08 1PATCH;IONTOPHORESIS, TOPICAL

09 16SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

10 4SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

11 11SOLUTION;INTRAVENOUS

12 3SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS

13 1SOLUTION;IONTOPHORESIS

14 1SOLUTION;IONTOPHORESIS, TOPICAL

15 2SPRAY;NASAL

16 1TABLET;ORAL

filter Regulatory Info Reset all filters

105 All

01 45DISCN

02 1OTC

03 56RX

04 3Blank

filter Brand Name Reset all filters

105 All

01 2ADRENACLICK

02 7ADRENALIN

03 3AUVI-Q

04 1BETAMETHASONE DIPROPIONATE

05 1BRONKAID MIST

06 1DOCETAXEL

07 1DURANEST

08 1EPI E Z PEN JR

09 22EPINEPHRINE

10 2EPINEPHRINE (AUTOINJECTOR)

11 1EPIPEN

12 1EPIPEN E Z PEN

13 1EPIPEN JR.

14 1IONTOCAINE

15 16LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

16 9LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE

17 3LIDOCATON

18 1LIDOSITE TOPICAL SYSTEM KIT

19 2NEFFY

20 2OCTOCAINE

21 2PRIMATENE MIST

22 2PROCAINE HYDROCHLORIDE W/ EPINEPHRINE

23 3SODIUM NITROPRUSSIDE

24 1SUNITINIB MALATE

25 2SUS-PHRINE SULFITE FREE

26 1SYMJEPI

27 1TEMOZOLOMIDE

28 1THEOPHYL-225

29 2TWINJECT

30 2XYLOCAINE DENTAL WITH EPINEPHRINE

31 10XYLOCAINE W/ EPINEPHRINE

filter RLD Reset all filters

105 All

01 65No

02 37Yes

03 3Blank

List of Suppliers

Product Main Page

01

ASTRAZENECA

PEGS Boston Summit

Not Confirmed

ASTRAZENECA

PEGS Boston Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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RLD : No

TE Code :

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Brand Name : XYLOCAINE W/ EPINEPHRINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.005MG/ML;1%

Approval Date : 1982-01-01

Application Number : 10418

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

FOREST LABS

PEGS Boston Summit

Not Confirmed

FOREST LABS

PEGS Boston Summit

Not Confirmed

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RLD : No

TE Code :

EPINEPHRINE

Brand Name : SUS-PHRINE SULFITE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5MG/ML

Approval Date : 1982-01-01

Application Number : 7942

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

FOREST LABS

PEGS Boston Summit

Not Confirmed

FOREST LABS

PEGS Boston Summit

Not Confirmed

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RLD : No

TE Code :

EPINEPHRINE

Brand Name : SUS-PHRINE SULFITE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1.5MG/AMP

Approval Date : 1999-02-05

Application Number : 7942

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Brand Name : XYLOCAINE W/ EPINEPHRINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.01MG/ML;2%

Approval Date : 1982-01-01

Application Number : 6488

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

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RLD : Yes

TE Code : AP

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Brand Name : XYLOCAINE W/ EPINEPHRINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.01MG/ML;1%

Approval Date : 1982-01-01

Application Number : 6488

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

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RLD : Yes

TE Code :

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Brand Name : XYLOCAINE W/ EPINEPHRINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.02MG/ML;2%

Approval Date : 1982-01-01

Application Number : 6488

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

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RLD : Yes

TE Code : AP

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Brand Name : XYLOCAINE W/ EPINEPHRINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.005MG/ML;0.5%

Approval Date : 1982-01-01

Application Number : 6488

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AP

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Brand Name : XYLOCAINE W/ EPINEPHRINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.005MG/ML;1.5%

Approval Date : 1982-01-01

Application Number : 6488

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

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Post an Enquiry

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RLD : Yes

TE Code :

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Brand Name : XYLOCAINE W/ EPINEPHRINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.005MG/ML;1%

Approval Date : 1986-11-13

Application Number : 6488

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

FRESENIUS KABI USA

PEGS Boston Summit

Not Confirmed

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RLD : Yes

TE Code : AP

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Brand Name : XYLOCAINE W/ EPINEPHRINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.005MG/ML;2%

Approval Date : 1986-11-13

Application Number : 6488

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Portfolio PDF

Product Web Link

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Corporate PDF

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.