Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078373
Company: SAGENT PHARMS INC
Company: SAGENT PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Prescription | AP1 | No | No |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | AP1 | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/23/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2019 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
03/15/2010 | SUPPL-4 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
02/24/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION; 30MG/10ML (3MG/ML)
TE Code = AP1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP1 | 021113 | HIKMA |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP1 | 078373 | SAGENT PHARMS INC |
INJECTABLE;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP1 | 021113 | HIKMA |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP1 | 078373 | SAGENT PHARMS INC |