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Details for New Drug Application (NDA): 020479

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NDA 020479 describes GASTROCROM, which is a drug marketed by Meda Pharms 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:
GASTROCROM
Applicant:
Meda Pharms
Ingredient:
cromolyn sodium
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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms
GASTROCROM
cromolyn sodium
CONCENTRATE;ORAL020479-001Feb 29, 19964,421,762► subscribe
Meda Pharms
GASTROCROM
cromolyn sodium
CONCENTRATE;ORAL020479-001Feb 29, 19964,515,805► subscribe
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