Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078156
Company: DR REDDYS
Company: DR REDDYS
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 | AP2 | No | No |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 60MG/10ML (6MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | AP2 | 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 |
---|---|---|---|---|---|---|---|
08/19/2008 | 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 |
---|---|---|---|---|---|
08/01/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
10/16/2009 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION; 30MG/10ML (3MG/ML)
TE Code = AP2
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 | No | AP2 | 078156 | DR REDDYS |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP2 | 075841 | HOSPIRA |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP2 | 078520 | MYLAN LABS LTD |
INJECTABLE;INJECTION; 60MG/10ML (6MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 60MG/10ML (6MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078156 | DR REDDYS |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 60MG/10ML (6MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 075841 | HOSPIRA |
INJECTABLE;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP2
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 | No | AP2 | 078156 | DR REDDYS |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP2 | 075841 | HOSPIRA |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP2 | 078520 | MYLAN LABS LTD |