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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020479

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NDA 020479 describes GASTROCROM, which is a drug marketed by Mylan Speciality Lp and Ucb Inc and is included in two NDAs. It is available from four suppliers. Additional details are available on the GASTROCROM profile page.

The generic ingredient in GASTROCROM is cromolyn sodium. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

Summary for NDA: 020479

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020479

Physiological EffectDecreased Histamine Release

Suppliers and Packaging for NDA: 020479

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GASTROCROM
cromolyn sodium
CONCENTRATE;ORAL 020479 NDA MEDA Pharmaceuticals 0037-0678 0037-0678-96 12 POUCH in 1 CARTON (0037-0678-96) > 8 AMPULE in 1 POUCH (0037-0678-08) > 5 mL in 1 AMPULE
GASTROCROM
cromolyn sodium
CONCENTRATE;ORAL 020479 NDA Jazz Pharmaceuticals Commercial Corp. 18860-678 18860-678-70 12 POUCH in 1 CARTON (18860-678-70) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength100MG/5ML
Approval Date:Feb 29, 1996TE:AARLD:Yes

Expired Orange Book Patents for NDA: 020479

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp
GASTROCROM
cromolyn sodium
CONCENTRATE;ORAL020479-001Feb 29, 1996► Subscribe► Subscribe
Mylan Speciality Lp
GASTROCROM
cromolyn sodium
CONCENTRATE;ORAL020479-001Feb 29, 1996► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Teva
QuintilesIMS
Colorcon
US Department of Justice
Queensland Health
UBS
Dow
Express Scripts
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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