Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020479
Company: MYLAN SPECIALITY LP
Company: MYLAN SPECIALITY LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GASTROCROM | CROMOLYN SODIUM | 100MG/5ML | CONCENTRATE;ORAL | Prescription | AA | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/29/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/13/2003 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20479slr005ltr.pdf |
12/16/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/08/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/10/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
GASTROCROM
CONCENTRATE;ORAL; 100MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CROMOLYN SODIUM | CROMOLYN SODIUM | 100MG/5ML | CONCENTRATE;ORAL | Prescription | No | AA | 209264 | AILEX PHARMS LLC |
CROMOLYN SODIUM | CROMOLYN SODIUM | 100MG/5ML | CONCENTRATE;ORAL | Prescription | No | AA | 202745 | MICRO LABS LTD INDIA |
CROMOLYN SODIUM | CROMOLYN SODIUM | 100MG/5ML | CONCENTRATE;ORAL | Prescription | No | AA | 202583 | RISING PHARMA |
GASTROCROM | CROMOLYN SODIUM | 100MG/5ML | CONCENTRATE;ORAL | Prescription | Yes | AA | 020479 | MYLAN SPECIALITY LP |