Details for New Drug Application (NDA): 207029
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The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are sixty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 207029
Tradename: | HYDROCORTISONE |
Applicant: | Strides Pharma |
Ingredient: | hydrocortisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207029
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 207029
Suppliers and Packaging for NDA: 207029
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 207029 | ANDA | Strides Pharma Inc. | 42543-970 | 42543-970-25 | 50 TABLET in 1 BOTTLE, PLASTIC (42543-970-25) |
HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 207029 | ANDA | Strides Pharma Inc. | 42543-971 | 42543-971-06 | 100 TABLET in 1 BOTTLE, PLASTIC (42543-971-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 27, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 27, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 27, 2017 | TE: | AB | RLD: | No |
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