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Details for New Drug Application (NDA): 075702

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NDA 075702 describes CROMOLYN SODIUM, which is a drug marketed by Actavis Mid Atlantic, Bausch And Lomb, Akorn, Mylan Speclt, Apotex Inc, Perrigo, Pharmascience Inc, Micro Labs Ltd India, Wockhardt, Genera Pharms, Watson Labs, Teva Pharms, Roxane, Hh And P, Alcon, and Pack Pharms Llc, and is included in nineteen NDAs. It is available from eleven suppliers. Additional details are available on the CROMOLYN SODIUM profile page.

The generic ingredient in CROMOLYN SODIUM 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: 075702

Tradename:
CROMOLYN SODIUM
Applicant:
Bausch And Lomb
Ingredient:
cromolyn sodium
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 075702

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CROMOLYN SODIUM
cromolyn sodium
SPRAY, METERED;NASAL 075702 ANDA Major Pharmaceuticals 0904-5532 0904-5532-67 1 BOTTLE in 1 CARTON (0904-5532-67) > 26 mL in 1 BOTTLE
CROMOLYN SODIUM
cromolyn sodium
SPRAY, METERED;NASAL 075702 ANDA Cardinal Health 37205-223 37205-223-61 1 BOTTLE in 1 CARTON (37205-223-61) > 26 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SPRAY, METERED;NASALStrength5.2MG/SPRAY
Approval Date:Jul 3, 2001TE:RLD:Yes


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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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