Details for New Drug Application (NDA): 019781
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NDA 019781 describes PROMETRIUM, which is a drug marketed by Acertis Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the PROMETRIUM profile page.
The generic ingredient in PROMETRIUM is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.
The generic ingredient in PROMETRIUM is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 019781
| Tradename: | PROMETRIUM |
| Applicant: | Acertis Pharms |
| Ingredient: | progesterone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019781
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETRIUM | progesterone | CAPSULE;ORAL | 019781 | NDA | Acertis Pharmaceuticals, LLC | 72989-372 | 72989-372-30 | 30 CAPSULE in 1 BOTTLE (72989-372-30) |
| PROMETRIUM | progesterone | CAPSULE;ORAL | 019781 | NDA | Acertis Pharmaceuticals, LLC | 72989-373 | 72989-373-30 | 30 CAPSULE in 1 BOTTLE (72989-373-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | May 14, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Oct 15, 1999 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Oct 15, 1999 | TE: | RLD: | No | |||||
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