Details for New Drug Application (NDA): 201270
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The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are thirty-nine drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.
Summary for 201270
Tradename: | DEXAMETHASONE |
Applicant: | Larken Labs Inc |
Ingredient: | dexamethasone |
Patents: | 0 |
Pharmacology for NDA: 201270
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 201270
Suppliers and Packaging for NDA: 201270
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | dexamethasone | TABLET;ORAL | 201270 | ANDA | Larken Laboratories, Inc. | 68047-702 | 68047-702-01 | 100 TABLET in 1 BOTTLE (68047-702-01) |
DEXAMETHASONE | dexamethasone | TABLET;ORAL | 201270 | ANDA | Larken Laboratories, Inc. | 68047-702 | 68047-702-21 | 21 TABLET in 1 DOSE PACK (68047-702-21) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
Approval Date: | Jul 17, 2017 | TE: | AB | RLD: | No |
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